FDA 510(k)

ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)

K-Number: K981221 · 1998-04-23

Decision Date1998-04-23

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-04-23 under 510(k) number K981221. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)?

ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) is a medical device that received FDA 510(k) clearance on 1998-04-23. The listed applicant is Abbott Laboratories. The 510(k) number is K981221.

When did ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) receive FDA 510(k) clearance?

ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) received FDA 510(k) clearance on 1998-04-23, under 510(k) number K981221.

Who is the listed applicant for ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)?

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

What is the FDA product code for ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED)?

The FDA product code for ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) is CIT.

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Related Devices (Code: CIT)

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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.