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FDA 510(k)

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT

K-Number: K864357 · 1987-02-06

ApplicantTrace Scientific , Ltd.
Decision Date1987-02-06
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K864357. 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 AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT?

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K864357.

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

AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT received FDA 510(k) clearance on 1987-02-06, under 510(k) number K864357.

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

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Trace Scientific , Ltd. as applicant

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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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