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FDA 510(k)

HOMOCYSTEINE MICROTITER PLATE ASSAY

K-Number: K032012 · 2003-09-03

ApplicantDiazyme Laboratories
Decision Date2003-09-03
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOMOCYSTEINE MICROTITER PLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2003-09-03 under 510(k) number K032012. The device is classified under product code LPS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOMOCYSTEINE MICROTITER PLATE ASSAY?

HOMOCYSTEINE MICROTITER PLATE ASSAY is a medical device that received FDA 510(k) clearance on 2003-09-03. The listed applicant is Diazyme Laboratories. The 510(k) number is K032012.

When did HOMOCYSTEINE MICROTITER PLATE ASSAY receive FDA 510(k) clearance?

HOMOCYSTEINE MICROTITER PLATE ASSAY received FDA 510(k) clearance on 2003-09-03, under 510(k) number K032012.

Who is the listed applicant for HOMOCYSTEINE MICROTITER PLATE ASSAY?

The FDA 510(k) record lists Diazyme Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOMOCYSTEINE MICROTITER PLATE ASSAY?

The FDA product code for HOMOCYSTEINE MICROTITER PLATE ASSAY is LPS.

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Related Devices (Code: LPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123930VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K121053DIAZYME HOMOCYSTEINE POC TEST KITDiazyme LaboratoriesK121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.K113793HOMOCYSTEINE TESTRocheK112790AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRONAxis-Shield Diagnostics, Ltd.K083222AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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