Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032900

FEI Number

3004445302

Entity Name

Diazyme Laboratories, Inc.

City/State/Country

POWAY, CA, US

Establishment Address

12889 GREGG CT, POWAY, CA 92064, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diazyme Laboratories, Inc. (Owner Number: 9057184)

Owner / Operator Contact Address

12889 Gregg Court, --, Poway, CA 92064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060619

PMA Number

N/A

All Registered Proprietary Names

Homocysteine Enzymatic Control Set Diazyme Homocysteine 2 Reagent Enzymatic Assay Homocysteine Enzymatic Assay 5 Point Calibrator Set HDL-LDL Cholesterol Calibrator HDL-Cholesterol Assay Diazyme Myoglobin Assay Diazyme Myoglobin Control Set Diazyme Myoglobin Calibrator Set Glycated Serum Protein Calibrator Set Glycated Serum Protein Assay Glycated Serum Protein Control Set Diazyme Lipoprotein (a) Assay Diazyme Cystatin C Control Set Diazyme Cystatin C Calibrator Set Diazyme Cystatin C Assay Diazyme EZ Vitamin D Assay Diazyme EZ Vitamin D Calibrator Set Diazyme EZ Vitamin D Control Set Homocysteine Enzymatic Assay Auto-dilution Calibrator Homocysteine Enzymatic Control Set Homocysteine Enzymatic Assay 5 Point Calibrator Set Homocysteine Enzymatic Assay Diazyme Retinol Binding Protein Assay Calibrator Set Diazyme Retinol Binding Protein Assay Control Set Diazyme Retinol Binding Protein Assay Apolipoprotein A-1 Assay Apolipoprotein A-1/B Calibrator Diazyme 1,5 Anhydroglucitol (1,5, AG) Assay Calibrator Set Diazyme 1,5 Anhydroglucitol (1,5 AG) Control Set Diazyme 1,5 Anhydroglucitol (1,5,AG) Assay 5'-Nucleotidase Control Set 5'-Nucleotidase Calibrator 5'-Nucleotidase Assay Apolipoprotein B Assay Apolipoprotein A-1/B Calibrator Diazyme Liquid Stable Enzymatic Lithium Control Set Diazyme Liquid Stable Enzymatic Lithium Calibrator Set Diazyme Liquid Stable Enzymatic Lithium Assay Homocysteine Control Kit Homocysteine Calibrator Kit Diazyme Oxalate Enzymatic Assay Diazyme b- Hydroxybutyrate (BHB) Calibrator Diazyme b- Hydroxybutyrate (BHB) Controls Diazyme b- Hydroxybutyrate (BHB) Assay Diazyme Direct HbA1c Assay Calibrator Set Diazyme Direct HbA1c Assay Control Set Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis) Diazyme OxLDL Assay Creatinine Liquid Reagent Assay Control Creatinine Liquid Reagent Assay Creatinine Liquid Reagent Assay Calibrator Diazyme Liquid Stable Enzymatic Potassium Calibrator Set Diazyme Liquid Stable Enzymatic Potassium Assay Diazyme Liquid Stable Enzymatic Potassium Control Set Lipase Control Set Lipase Calibrator Lipase Assay Kappa Lambda FLTC Controls REF 06U9510 Lambda FLC Reagent 100T REF 06U9626 Diazyme Human Kappa Free Light Chain Assay Diazyme Human Kappa/Lambda Free Light Chain Control Set Diazyme Human Lambda Free Light Chain Calibrator Set Diazyme Human Kappa Free Light Chain Calibrator Set KFLC Kappa Free Light Chains REF URCI 08896534190 KFLC Kappa Free Light Chains REF URCIII 08896640190 Diazyme Human Lambda Free Light Chain Assay KFLC Kappa Free Light Chains REF URCII 08896542190 Kappa-Lambda FLC Control Set REF 08896577190 LFLC Lambda Free Light Chains REF URCII 08896658190 LFLC Lambda Free Light Chains REF URCI 08896569190 LFLC Lambda Free Light Chains REF URCIII 08896631190 Kappa FLC Reagent 100T REF 06U9525 DzLite c270 HDL-LDL Cholesterol Calibrator LDL-Cholesterol Assay Diazyme Calprotectin Assay Diazyme Calprotectin Control Set Diazyme Calprotectin Calibrator Set Diazyme Lipoprotein (a) Control Set Diazyme Lipoprotein (a) Calibrator Set Diazyme D-Dimer Assay Diazyme D-Dimer Control Set Diazyme D-Dimer Calibrator Set Diazyme Carbon Dioxide Enzymatic Assay Kit Diazyme Carbon Dioxide Enzymatic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2008-11-26
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-11-26
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2008-11-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-11-20
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2013-11-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-10-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-10-21
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2011-10-21
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2018-10-11
NDY	Test, Cystatin C	Clinical Chemistry	Class 2	862.1225	2010-12-16
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2019-03-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2006-01-03
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2006-01-03
CZS	Retinol-Binding Protein, Antigen, Antiserum, Control	Immunology	Class 1	866.5765	2019-03-19
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2008-11-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-11-26
NOZ	Assay, 1,5-Anhydroglucitol (15ag)	Hematology	Class 2	864.7470	2019-03-19
CED	5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase	Clinical Chemistry	Class 1	862.1520	2009-12-02
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2008-04-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-04-28
JII	Atomic Absorption, Lithium	Clinical Toxicology	Class 2	862.3560	2009-12-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2020-05-27
LPS	Urinary Homocystine (Nonquantitative) Test System	Clinical Chemistry	Class 2	862.1377	2020-05-27
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2020-05-27
LPW	System, Test, Oxalate	Clinical Chemistry	Class 1	862.1542	2026-05-06
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2023-01-17
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2017-11-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-11-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-11-16
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2026-05-06
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2008-11-26
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
MZV	Test, System, Potassium, Enzymatic Method	Clinical Chemistry	Class 2	862.1600	2009-12-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-12-02
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-12-02
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2007-11-06
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-10-11
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2018-10-11
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2024-01-09
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-01-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2008-11-26
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2024-01-04
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-11-20
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2013-11-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-11-20
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2013-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2008-11-26

Official Correspondent

Abhijit Datta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diazyme 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
K061598	Instrumentation Laboratory CO	HEMOSIL HOMOCYSTEINE AND CONTROLS	2006-09-22
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24

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-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
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.

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3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032900. Last updated year: 2026. Please use registration number 2032900 when referencing this establishment in official correspondence.