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FDA 510(k)

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

K-Number: K891468 · 1989-05-22

ApplicantTrace Scientific , Ltd.
Decision Date1989-05-22
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT 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 1989-05-22 under 510(k) number K891468. 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) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K891468.

When did AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT receive FDA 510(k) clearance?

AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT received FDA 510(k) clearance on 1989-05-22, under 510(k) number K891468.

Who is the listed applicant for AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

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) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

The FDA product code for AST (GOT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT 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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