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FDA 510(k)

ALANINE AMINOTRANSFERASE REAGENT SYSTEM

K-Number: K952744 · 1995-08-07

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1995-08-07
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALANINE 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 1995-08-07 under 510(k) number K952744. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALANINE AMINOTRANSFERASE REAGENT SYSTEM?

ALANINE AMINOTRANSFERASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-07. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K952744.

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

ALANINE AMINOTRANSFERASE REAGENT SYSTEM received FDA 510(k) clearance on 1995-08-07, under 510(k) number K952744.

Who is the listed applicant for ALANINE 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 ALANINE AMINOTRANSFERASE REAGENT SYSTEM?

The FDA product code for ALANINE AMINOTRANSFERASE REAGENT SYSTEM is CKA.

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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: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

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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