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FDA 510(k)

ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT

K-Number: K860727 · 1986-04-07

ApplicantTrace Scientific , Ltd.
Decision Date1986-04-07
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K860727. 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 ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT?

ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K860727.

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

ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860727.

Who is the listed applicant for ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT?

The FDA product code for ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT is CKA.

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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.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

View all 55 devices →

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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