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FDA 510(k)

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY

K-Number: K040293 · 2004-05-28

ApplicantAkers Laboratories, Inc.
Decision Date2004-05-28
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Akers Laboratories, Inc.. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K040293. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY?

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Akers Laboratories, Inc.. The 510(k) number is K040293.

When did HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY receive FDA 510(k) clearance?

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY received FDA 510(k) clearance on 2004-05-28, under 510(k) number K040293.

Who is the listed applicant for HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY?

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

What is the FDA product code for HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY?

The FDA product code for HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY is LCO.

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Other records listing Akers Laboratories, Inc. as applicant

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.

K031579INSTAREAD LITHIUM SYSTEMK030815AKERS LABORATORIES INC. BLOOD CELL SEPARATOR

Related Devices (Code: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory COK153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory COK071781PF4 IGGGenetic Testing Institute

Official Source

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

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