PARAMAX ALKALINE PHOSPHATASE REAGENT-— 510(k) K831480

Name: FDA 510(k) clearance K831480
Creator: U.S. Food and Drug Administration
Published: 1983-06-22

Substantially Equivalent

American Dade

FDA 510(k) clearance K831480 for PARAMAX ALKALINE PHOSPHATASE REAGENT-, Substantially Equivalent on 1983-06-22. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 1983-05-09
Decision date: 1983-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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