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FDA 510(k)

GOT ISOENZYME ASSAY EIKEN KIT

K-Number: K802447 · 1981-04-17

ApplicantSyn-Kit, Inc.
Decision Date1981-04-17
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GOT ISOENZYME ASSAY EIKEN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K802447. 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 GOT ISOENZYME ASSAY EIKEN KIT?

GOT ISOENZYME ASSAY EIKEN KIT is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K802447.

When did GOT ISOENZYME ASSAY EIKEN KIT receive FDA 510(k) clearance?

GOT ISOENZYME ASSAY EIKEN KIT received FDA 510(k) clearance on 1981-04-17, under 510(k) number K802447.

Who is the listed applicant for GOT ISOENZYME ASSAY EIKEN KIT?

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

What is the FDA product code for GOT ISOENZYME ASSAY EIKEN KIT?

The FDA product code for GOT ISOENZYME ASSAY EIKEN KIT is CIT.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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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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