COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S— 510(k) K963111

Substantially Equivalent

Chromogenix AB

FDA 510(k) clearance K963111 for COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S, Substantially Equivalent on 1996-12-23. Applicant: Chromogenix AB.

Clearance details

Applicant: Chromogenix AB
Product code: Code GGW
Advisory panel: Hematology
Date received: 1996-08-12
Decision date: 1996-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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