PROTOTRO/PROTEOLYTIC ENZYME CONTROL— 510(k) K831297

Name: FDA 510(k) clearance K831297
Creator: U.S. Food and Drug Administration
Published: 1983-06-08

Substantially Equivalent

American Dade

FDA 510(k) clearance K831297 for PROTOTRO/PROTEOLYTIC ENZYME CONTROL, Substantially Equivalent on 1983-06-08. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1983-04-21
Decision date: 1983-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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