GGT REAGENT— 510(k) K905618

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K905618 for GGT REAGENT, Substantially Equivalent on 1991-02-26. Applicant: Amresco, Inc.. Device class: 1.

Clearance details

Applicant: Amresco, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1990-12-14
Decision date: 1991-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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K903304 — ROCHE COBAS READY GGT REAGENT1990-10-12

More clearances from Amresco, Inc.

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
K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/71731990-12-11

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