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FDA 510(k)

STANBIO ALT/GPT (LUQUI-UV) TEST SET

K-Number: K941314 · 1994-07-20

ApplicantStanbio Laboratory
Decision Date1994-07-20
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO ALT/GPT (LUQUI-UV) TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1994-07-20 under 510(k) number K941314. 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 STANBIO ALT/GPT (LUQUI-UV) TEST SET?

STANBIO ALT/GPT (LUQUI-UV) TEST SET is a medical device that received FDA 510(k) clearance on 1994-07-20. The listed applicant is Stanbio Laboratory. The 510(k) number is K941314.

When did STANBIO ALT/GPT (LUQUI-UV) TEST SET receive FDA 510(k) clearance?

STANBIO ALT/GPT (LUQUI-UV) TEST SET received FDA 510(k) clearance on 1994-07-20, under 510(k) number K941314.

Who is the listed applicant for STANBIO ALT/GPT (LUQUI-UV) TEST SET?

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

What is the FDA product code for STANBIO ALT/GPT (LUQUI-UV) TEST SET?

The FDA product code for STANBIO ALT/GPT (LUQUI-UV) TEST SET is CKA.

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Other records listing Stanbio Laboratory 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.

K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050283CREATININE LIQUICOLORK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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