CREATINE PHOSPHOKINASE— 510(k) K903775

Substantially Equivalent

Amresco, Inc.

FDA 510(k) clearance K903775 for CREATINE PHOSPHOKINASE, Substantially Equivalent on 1990-10-04. Applicant: Amresco, Inc.. Device class: 2.

Clearance details

Applicant: Amresco, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1990-08-20
Decision date: 1990-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solon, OH, US

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More clearances from Amresco, Inc.

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.