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

Name: FDA 510(k) clearance K963111
Creator: U.S. Food and Drug Administration
Published: 1996-12-23

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. Device class: 2.

Clearance details

Applicant: Chromogenix AB
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1996-08-12
Decision date: 1996-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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