BOVINE CHEMISTRY CONTROL I.X AND II.X— 510(k) K860355

Substantially Equivalent

American Dade

FDA 510(k) clearance K860355 for BOVINE CHEMISTRY CONTROL I.X AND II.X, Substantially Equivalent on 1986-03-17. Applicant: American Dade. Device class: 1.

Clearance details

Applicant
American Dade
Product code
Code JJY
Device class
Class 1
Regulation
21 CFR 862.1660
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Ana, CA, US
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