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FDA 510(k)

FLOW-PAC SGOT REAGENT

K-Number: K830958 · 1983-05-04

ApplicantAmresco, Inc.
Decision Date1983-05-04
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC SGOT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1983-05-04 under 510(k) number K830958. 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 FLOW-PAC SGOT REAGENT?

FLOW-PAC SGOT REAGENT is a medical device that received FDA 510(k) clearance on 1983-05-04. The listed applicant is Amresco, Inc.. The 510(k) number is K830958.

When did FLOW-PAC SGOT REAGENT receive FDA 510(k) clearance?

FLOW-PAC SGOT REAGENT received FDA 510(k) clearance on 1983-05-04, under 510(k) number K830958.

Who is the listed applicant for FLOW-PAC SGOT REAGENT?

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

What is the FDA product code for FLOW-PAC SGOT REAGENT?

The FDA product code for FLOW-PAC SGOT REAGENT is CIT.

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Other records listing Amresco, Inc. as applicant

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K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK905284HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173K904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116

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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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