RAICHEM ALKALINE PHOSPHATASE REAGENT— 510(k) K832463

Name: FDA 510(k) clearance K832463
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Reagents Applications, Inc.

FDA 510(k) clearance K832463 for RAICHEM ALKALINE PHOSPHATASE REAGENT, Substantially Equivalent on 1983-09-12. Applicant: Reagents Applications, Inc.. Device class: 2.

Clearance details

Applicant: Reagents Applications, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1983-07-26
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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