FDA product code CIF: Vanillin Pyruvate, Ast/Sgot

CIF is the FDA product code for vanillin pyruvate, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CIF. The average 510(k) review took 59 days (median 59).

Classification

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

Top CIF applicants

Most recent CIF clearances

Recalls for CIF devices

openFDA lists no recalls for product code CIF.

Frequently asked questions

What is FDA product code CIF?

CIF is the FDA product code for vanillin pyruvate, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel.

What device class is CIF?

Class II, regulation 21 CFR 862.1100. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 59 days from receipt to decision (median 59).

Which companies have the most CIF clearances?

Miles Laboratories, Inc. (1).

Next steps

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