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FDA 510(k)

PLUS CHEM, DETERMINATION OF ALT (GPT)

K-Number: K791084 · 1979-07-17

ApplicantSmithkline Diagnostics, Inc.
Decision Date1979-07-17
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PLUS CHEM, DETERMINATION OF ALT (GPT) is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K791084. 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 PLUS CHEM, DETERMINATION OF ALT (GPT)?

PLUS CHEM, DETERMINATION OF ALT (GPT) is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K791084.

When did PLUS CHEM, DETERMINATION OF ALT (GPT) receive FDA 510(k) clearance?

PLUS CHEM, DETERMINATION OF ALT (GPT) received FDA 510(k) clearance on 1979-07-17, under 510(k) number K791084.

Who is the listed applicant for PLUS CHEM, DETERMINATION OF ALT (GPT)?

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

What is the FDA product code for PLUS CHEM, DETERMINATION OF ALT (GPT)?

The FDA product code for PLUS CHEM, DETERMINATION OF ALT (GPT) is CKA.

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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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