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FDA 510(k)

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT

K-Number: K803216 · 1981-01-09

ApplicantUnion Carbide Corp.
Decision Date1981-01-09
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1981-01-09 under 510(k) number K803216. 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 CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT?

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT is a medical device that received FDA 510(k) clearance on 1981-01-09. The listed applicant is Union Carbide Corp.. The 510(k) number is K803216.

When did CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT receive FDA 510(k) clearance?

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT received FDA 510(k) clearance on 1981-01-09, under 510(k) number K803216.

Who is the listed applicant for CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT?

The FDA product code for CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT is CIT.

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Other records listing Union Carbide Corp. as applicant

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K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

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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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