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FDA 510(k)

ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM

K-Number: K952743 · 1995-09-29

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1995-09-29
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1995-09-29 under 510(k) number K952743. 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 ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM?

ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-29. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K952743.

When did ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM receive FDA 510(k) clearance?

ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM received FDA 510(k) clearance on 1995-09-29, under 510(k) number K952743.

Who is the listed applicant for ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM?

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

What is the FDA product code for ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM?

The FDA product code for ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM is CIT.

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Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

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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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