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FDA 510(k)

SGOT/ALT REAGENT

K-Number: K852783 · 1985-07-22

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-07-22
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SGOT/ALT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-07-22 under 510(k) number K852783. 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 SGOT/ALT REAGENT?

SGOT/ALT REAGENT is a medical device that received FDA 510(k) clearance on 1985-07-22. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K852783.

When did SGOT/ALT REAGENT receive FDA 510(k) clearance?

SGOT/ALT REAGENT received FDA 510(k) clearance on 1985-07-22, under 510(k) number K852783.

Who is the listed applicant for SGOT/ALT REAGENT?

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

What is the FDA product code for SGOT/ALT REAGENT?

The FDA product code for SGOT/ALT REAGENT is CIT.

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Other records listing Advanced Biomedical Methods, 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.

K945353CLARIT(TM)K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERK864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZERK850380INORGANIC PHOSPHOROUS FOR DEMAND 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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