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FDA 510(k)

IN-VITRO TEST DETERMINATION OF SGOT (AST)

K-Number: K854187 · 1985-11-25

ApplicantClinical Data, Inc.
Decision Date1985-11-25
Product CodeCIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN-VITRO TEST DETERMINATION OF SGOT (AST) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854187. The device is classified under product code CIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-VITRO TEST DETERMINATION OF SGOT (AST)?

IN-VITRO TEST DETERMINATION OF SGOT (AST) is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is Clinical Data, Inc.. The 510(k) number is K854187.

When did IN-VITRO TEST DETERMINATION OF SGOT (AST) receive FDA 510(k) clearance?

IN-VITRO TEST DETERMINATION OF SGOT (AST) received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854187.

Who is the listed applicant for IN-VITRO TEST DETERMINATION OF SGOT (AST)?

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

What is the FDA product code for IN-VITRO TEST DETERMINATION OF SGOT (AST)?

The FDA product code for IN-VITRO TEST DETERMINATION OF SGOT (AST) is CIS.

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Related Devices (Code: CIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)Cholestech Corp.K896238COBAS READY AST REAGENTRoche Diagnostic Systems, Inc.K812872OPTIONAL TOTAL CA-MODULE FOR IL 504/508Instrumentation Laboratory COK792410ELVI SGOT & SGPT TRANSAMINASEVolu Sol Medical Industries

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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