FDA 510(k)

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS

K-Number: K080485 · 2008-12-04

ApplicantDiasys Diagnostics Systems GmbH

Decision Date2008-12-04

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS is the device name listed in this FDA 510(k) record. The listed applicant is Diasys Diagnostics Systems GmbH. It received FDA 510(k) clearance on 2008-12-04 under 510(k) number K080485. 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 AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS is a medical device that received FDA 510(k) clearance on 2008-12-04. The listed applicant is Diasys Diagnostics Systems GmbH. The 510(k) number is K080485.

When did ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS receive FDA 510(k) clearance?

ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS received FDA 510(k) clearance on 2008-12-04, under 510(k) number K080485.

Who is the listed applicant for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

The FDA 510(k) record lists Diasys Diagnostics Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS?

The FDA product code for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS 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.