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FDA 510(k)

STANBIO Y-GT (LIQUICOLOR) TEST SET

K-Number: K941315 · 1994-07-14

ApplicantStanbio Laboratory
Decision Date1994-07-14
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STANBIO Y-GT (LIQUICOLOR) 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 1994-07-14 under 510(k) number K941315. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANBIO Y-GT (LIQUICOLOR) TEST SET?

STANBIO Y-GT (LIQUICOLOR) TEST SET is a medical device that received FDA 510(k) clearance on 1994-07-14. The listed applicant is Stanbio Laboratory. The 510(k) number is K941315.

When did STANBIO Y-GT (LIQUICOLOR) TEST SET receive FDA 510(k) clearance?

STANBIO Y-GT (LIQUICOLOR) TEST SET received FDA 510(k) clearance on 1994-07-14, under 510(k) number K941315.

Who is the listed applicant for STANBIO Y-GT (LIQUICOLOR) 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 Y-GT (LIQUICOLOR) TEST SET?

The FDA product code for STANBIO Y-GT (LIQUICOLOR) TEST SET is JQB.

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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: JQB)

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.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, 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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