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FDA 510(k)

DATA-ZYME AST(GOT) PROCEDURE

K-Number: K801856 · 1980-09-16

ApplicantData Medical Associates, Inc.
Decision Date1980-09-16
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME AST(GOT) PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801856. 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 DATA-ZYME AST(GOT) PROCEDURE?

DATA-ZYME AST(GOT) PROCEDURE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K801856.

When did DATA-ZYME AST(GOT) PROCEDURE receive FDA 510(k) clearance?

DATA-ZYME AST(GOT) PROCEDURE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801856.

Who is the listed applicant for DATA-ZYME AST(GOT) PROCEDURE?

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

What is the FDA product code for DATA-ZYME AST(GOT) PROCEDURE?

The FDA product code for DATA-ZYME AST(GOT) PROCEDURE is CIT.

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Other records listing Data Medical Associates, Inc. as applicant

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K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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