FDA product code GKQ: Test, Thromboplastin Generation

GKQ is the FDA product code for test, thromboplastin generation. It is a Class I device, regulated under 21 CFR 864.7900 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under GKQ. The average 510(k) review took 29 days (median 29).

Classification

Compare with all 510(k) review times · Search every GKQ clearance

Top GKQ applicants

Most recent GKQ clearances

Recalls for GKQ devices

openFDA lists no recalls for product code GKQ.

Frequently asked questions

What is FDA product code GKQ?

GKQ is the FDA product code for test, thromboplastin generation. It is a Class I device, regulated under 21 CFR 864.7900 and reviewed by the Hematology panel.

What device class is GKQ?

Class I, regulation 21 CFR 864.7900. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code GKQ?

Across 1 cleared submissions the average was 29 days from receipt to decision (median 29).

Which companies have the most GKQ clearances?

Bd Becton Dickinson Vacutainer Systems Preanalytic (1).

Next steps

• Run an FDA pathway report with predicate devices for product code GKQ
• Run a recall and safety report across every GKQ manufacturer
• Watch product code GKQ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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