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FDA 510(k)

ALANINE TRANSAMINASE (ALT) TEST KIT

K-Number: K870879 · 1987-03-19

ApplicantGenetic Systems Corp.
Decision Date1987-03-19
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALANINE TRANSAMINASE (ALT) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Systems Corp.. It received FDA 510(k) clearance on 1987-03-19 under 510(k) number K870879. 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 TRANSAMINASE (ALT) TEST KIT?

ALANINE TRANSAMINASE (ALT) TEST KIT is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is Genetic Systems Corp.. The 510(k) number is K870879.

When did ALANINE TRANSAMINASE (ALT) TEST KIT receive FDA 510(k) clearance?

ALANINE TRANSAMINASE (ALT) TEST KIT received FDA 510(k) clearance on 1987-03-19, under 510(k) number K870879.

Who is the listed applicant for ALANINE TRANSAMINASE (ALT) TEST KIT?

The FDA 510(k) record lists Genetic Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALANINE TRANSAMINASE (ALT) TEST KIT?

The FDA product code for ALANINE TRANSAMINASE (ALT) TEST KIT is CKA.

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Other records listing Genetic Systems Corp. 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.

K891767GENETIC SYSTEMS MICROPLATE READERK891765GENETIC SYSTEMS PIPETTOR/DILUTORK891768GENETIC SYSTEMS MICROPLATE WASHERK891766GENETIC SYSTEMS MICROPLATE STRIP WASHERK890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITK873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES

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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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