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FDA 510(k)

COULTER ACCU-ZYME II GOT REAGENT

K-Number: K790483 · 1979-05-03

ApplicantCoulter Electronics, Inc.
Decision Date1979-05-03
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER ACCU-ZYME II GOT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1979-05-03 under 510(k) number K790483. 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 COULTER ACCU-ZYME II GOT REAGENT?

COULTER ACCU-ZYME II GOT REAGENT is a medical device that received FDA 510(k) clearance on 1979-05-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K790483.

When did COULTER ACCU-ZYME II GOT REAGENT receive FDA 510(k) clearance?

COULTER ACCU-ZYME II GOT REAGENT received FDA 510(k) clearance on 1979-05-03, under 510(k) number K790483.

Who is the listed applicant for COULTER ACCU-ZYME II GOT REAGENT?

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

What is the FDA product code for COULTER ACCU-ZYME II GOT REAGENT?

The FDA product code for COULTER ACCU-ZYME II GOT REAGENT is CIT.

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Other records listing Coulter Electronics, Inc. as applicant

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K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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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