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FDA 510(k)

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

K-Number: K052697 · 2006-01-04

ApplicantAkers Biosciences, Inc.
Decision Date2006-01-04
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Akers Biosciences, Inc.. It received FDA 510(k) clearance on 2006-01-04 under 510(k) number K052697. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL?

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL is a medical device that received FDA 510(k) clearance on 2006-01-04. The listed applicant is Akers Biosciences, Inc.. The 510(k) number is K052697.

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

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL received FDA 510(k) clearance on 2006-01-04, under 510(k) number K052697.

Who is the listed applicant for HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL?

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

What is the FDA product code for HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL?

The FDA product code for HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL is GGN.

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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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