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FDA 510(k)

COBAS REAGENT FOR AST (SGOT)

K-Number: K801118 · 1980-06-20

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-06-20
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR AST (SGOT) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801118. 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 COBAS REAGENT FOR AST (SGOT)?

COBAS REAGENT FOR AST (SGOT) is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801118.

When did COBAS REAGENT FOR AST (SGOT) receive FDA 510(k) clearance?

COBAS REAGENT FOR AST (SGOT) received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801118.

Who is the listed applicant for COBAS REAGENT FOR AST (SGOT)?

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

What is the FDA product code for COBAS REAGENT FOR AST (SGOT)?

The FDA product code for COBAS REAGENT FOR AST (SGOT) is CIT.

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Other records listing Roche Analytical Instruments, Inc. 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.

K801299COBAS CK-NAC REAGENTK801295COBAS REAGENT FOR A-AMYLASEK801298COBAS REAGENT FOR TRIGLYCERIDES & COBASK801296COBAS REAGENT FOR CHOLESTEROLK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACID

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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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