GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138— 510(k) K905096

Name: FDA 510(k) clearance K905096
Creator: U.S. Food and Drug Administration
Published: 1990-11-28

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K905096 for GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138, Substantially Equivalent on 1990-11-28. Applicant: Amresco, Inc.. Device class: 1.

Clearance details

Applicant: Amresco, Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1990-11-13
Decision date: 1990-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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Recent devices under product code JQB

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K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE1997-01-10

More clearances from Amresco, Inc.

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K905618 — GGT REAGENT1991-02-26
K904468 — DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/71761991-01-17
K905684 — ALKALINE PHOSPHATASE1990-12-28
K905544 — MAGNESIUM REAGENT1990-12-27
K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,71161990-12-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.