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FDA 510(k)

DIAZYME HOMOCYSTEINE POC TEST KIT

K-Number: K121053 · 2012-07-31

ApplicantDiazyme Laboratories
Decision Date2012-07-31
Product CodeLPS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME HOMOCYSTEINE POC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2012-07-31 under 510(k) number K121053. 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 DIAZYME HOMOCYSTEINE POC TEST KIT?

DIAZYME HOMOCYSTEINE POC TEST KIT is a medical device that received FDA 510(k) clearance on 2012-07-31. The listed applicant is Diazyme Laboratories. The 510(k) number is K121053.

When did DIAZYME HOMOCYSTEINE POC TEST KIT receive FDA 510(k) clearance?

DIAZYME HOMOCYSTEINE POC TEST KIT received FDA 510(k) clearance on 2012-07-31, under 510(k) number K121053.

Who is the listed applicant for DIAZYME HOMOCYSTEINE POC TEST KIT?

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 DIAZYME HOMOCYSTEINE POC TEST KIT?

The FDA product code for DIAZYME HOMOCYSTEINE POC TEST KIT 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.K121533ST 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.K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYAnticancer, Inc.

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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