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FDA 510(k)

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE

K-Number: K780505 · 1978-05-03

ApplicantGamma Enterprises, Inc.
Decision Date1978-05-03
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780505. 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 SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE?

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K780505.

When did SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE receive FDA 510(k) clearance?

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780505.

Who is the listed applicant for SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE?

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

What is the FDA product code for SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE?

The FDA product code for SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE is CIT.

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Other records listing Gamma Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780506CARBON DIOXIDE REAGENTSK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASEK771832CHLORIDE

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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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