Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221645

FEI Number

1221645

Entity Name

VERICHEM LABORATORIES, INC.

City/State/Country

Providence, RI, US

Establishment Address

90 NARRAGANSETT AVE., Providence, RI 02907, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VERICHEM LABORATORIES, INC. (Owner Number: 1221645)

Owner / Operator Contact Address

90 NARRAGANSETT AVE., --, Providence, RI 02907, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K880266

PMA Number

N/A

All Registered Proprietary Names

Urine Chemistry Standard Kit Electrolyte Standard Kit Carbon Dioxide Standard Kit, Level (F) Carbon Dioxide Standard Kit Carbon Dioxide Standard, 30 mmol/L HDL Cholesterol Verifier Kit Bilirubin Standard Kit Bilirubin Standard Level (F) BR2 Bilirubin Calibrator Total Protein/Albumin Level (F) Total Protein/Albumin Standard Kit Ethanol Standard Kit Ammonia/Iron Standard, Level (F) Ammonia/Iron Standard Kit Matrix Plus Chemistry Level (F) Matrix Plus Cholesterol Level (F) Matrix Plus Cholesterol Reference Matrix Plus Chemistry Reference Kit Microprotein Standard Kit Enzyme ER Verifier Kit Enzyme PLUS Verifier Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2007-12-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-28
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2011-01-10
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2007-12-28
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2007-12-28
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-01-10
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2007-12-28

Official Correspondent

ANTHONY DIMONTE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VERICHEM LABORATORIES, INC.

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
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0023-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022	Sentinel CH SpA Via Robert Koch	2	Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

Similar Registrations

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2050010	BECKMAN COULTER, INC.	CARLSBAD, CA, US
3003593973	Infrared Laboratory Systems dba SYNERMED	WESTFIELD, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221645. Last updated year: 2026. Please use registration number 1221645 when referencing this establishment in official correspondence.