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FDA 510(k)

DYNA ZYME II GOT 340

K-Number: K771153 · 1977-11-03

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-11-03
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNA ZYME II GOT 340 is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771153. 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 DYNA ZYME II GOT 340?

DYNA ZYME II GOT 340 is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771153.

When did DYNA ZYME II GOT 340 receive FDA 510(k) clearance?

DYNA ZYME II GOT 340 received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771153.

Who is the listed applicant for DYNA ZYME II GOT 340?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNA ZYME II GOT 340?

The FDA product code for DYNA ZYME II GOT 340 is CIT.

Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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