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FDA 510(k)

SERUM GLUTAMIC OXALOACETIC TRANSAMINASE

K-Number: K780013 · 1978-01-30

ApplicantMacomb Chemical Co.
Decision Date1978-01-30
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 Macomb Chemical Co.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K780013. 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 1978-01-30. The listed applicant is Macomb Chemical Co.. The 510(k) number is K780013.

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

SERUM GLUTAMIC OXALOACETIC TRANSAMINASE received FDA 510(k) clearance on 1978-01-30, under 510(k) number K780013.

Who is the listed applicant for SERUM GLUTAMIC OXALOACETIC TRANSAMINASE?

The FDA 510(k) record lists Macomb Chemical Co. 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 Macomb 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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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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