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FDA 510(k)

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

K-Number: K891469 · 1989-04-04

ApplicantTrace Scientific , Ltd.
Decision Date1989-04-04
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT 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 1989-04-04 under 510(k) number K891469. 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) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT is a medical device that received FDA 510(k) clearance on 1989-04-04. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K891469.

When did ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT receive FDA 510(k) clearance?

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT received FDA 510(k) clearance on 1989-04-04, under 510(k) number K891469.

Who is the listed applicant for ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

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) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT?

The FDA product code for ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT is CKA.

Related Clinical Trials

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

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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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