Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220972

FEI Number

1220972

Entity Name

MEDICA CORP.

City/State/Country

BEDFORD, MA, US

Establishment Address

5 OAK PARK DRIVE, BEDFORD, MA 01730, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDICA CORP. (Owner Number: 1220972)

Owner / Operator Contact Address

5 OAK PARK DRIVE, --, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111363

PMA Number

N/A

All Registered Proprietary Names

Barbiturates (BAR) EasyRA TBIL,DBIL,FE,PHOS,MG EasyRA Reag EasyCAL & EasyQC for EasyRA EasyLyte Na/K EtOH urine, EasyRA assay Amphetamines (AMP) EasyLyte Lithium EasyElectroLytes Na/K/Li RapidChem Na/K/Li AMY,BUN,TRIG,URIC,GLU-H EasyRA Reag EasyLyte Ca/Cl Oxycodone (OXY) GAMMA-GLUTAMYL TRANSFERASE (GGT) Reagent Total Protein (TP) Assay BZO Lactate Dehydrogenase (LDH) Assay EasyRA Creatinine Kinase (CK) Reagent EasyRA Total Bilirubin (TBIL) Reagent EasyRA Direct Bilirubin (DBIL) Reagent Capillary Adaptor Accessory EasyRA Creatinine (CREA) Reagent Cholesterol and Calcium EasyRA reag THC EasyLyte Na/K/Cl/Li EasyRA Lipase Reagent RapidPoint 350 EASYSTAT ALB,ALP,AST,CO2,CREA,CK EasyRA Reag EasyLyte Na/K/Ca/pH CK-MB EasyRA Reagent HDL EasyRA Reagent & Calibrator CREA-U Reagent micro-albumin in urine, EasyRA assay EasyBloodGas RapidPoint 340 Alanine aminotransferase(ALT) Assay PPX urine, EasyRA assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-03-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2013-03-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-03-14
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-08
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-08
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-08
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-01-08
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-01-08
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2008-01-08
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2008-01-08
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2009-03-10
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2009-03-10
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2009-03-10
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2009-03-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-02-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-02-14
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-02-14
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-02-14
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-07
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-07
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-02-14
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method	Clinical Toxicology	Class 2	862.3040	2012-02-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-02-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-03-14
DZK	Wire, Fixation, Intraosseous	Dental	Class 2	872.4880	2013-03-14
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-03-14
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-03-14
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2007-09-06
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-09-06
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2007-09-06
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-08
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2008-01-08
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-08
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2009-03-10
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2009-03-10
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2009-03-10
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-03-10
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2009-03-10
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-11
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-01-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-11
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2013-03-14
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-03-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-03-14
JPZ	Colorimetric Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2013-01-23
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2013-01-25
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2017-10-17
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2017-10-17
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2017-10-17
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2013-01-25
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2013-12-11
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-12-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-10
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2008-01-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-10
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-12-11
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2009-03-10
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2009-03-10
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2017-10-17
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2017-10-17
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-10-17
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2008-01-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2008-01-10
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2015-11-02
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	1992-07-06
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	1992-07-06
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	1992-07-06
GKF	Instrument, Hematocrit, Automated	Hematology	Class 2	864.5600	1992-07-06
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	1992-07-06
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	1992-07-06
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2009-03-10
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2009-03-10
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2009-03-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-03-10
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2009-03-10
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2009-03-10
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2009-03-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2008-01-08
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-01-08
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2008-01-08
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2008-01-08
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-05-23
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2014-05-23
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-05-23
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2014-05-23
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-03-10
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2009-03-10
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-03-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-02-14
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2012-02-14
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2008-01-08
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2013-01-25
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-02-14
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2012-02-14
LAS	Drug Specific Control Materials	Clinical Toxicology	Class 1	862.3280	2012-02-14

Official Correspondent

Photios Makris

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDICA CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K833577	Syva Co.	MODIF. OF EMIT URINE BARBITURATE	1984-01-26
K143535	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Secobarbital- Methadone	2015-01-13
K050024	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS	2005-11-17
K920417	Instrumentation Laboratory CO	IL TEST BARBITURATE, 35289	1992-04-24
K780731	Vitek Systems, Inc.	LIDOCAINE CALIBRATOR KIT	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2787-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2788-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-2789-2018	Guangzhou Wondfo Biotech Co., Ltd.	2	TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220972. Last updated year: 2026. Please use registration number 1220972 when referencing this establishment in official correspondence.