COATEST(R) APC(TM) RESISTANCE— 510(k) K945940

Name: FDA 510(k) clearance K945940
Creator: U.S. Food and Drug Administration
Published: 1995-08-07

Substantially Equivalent

Axis-Shield Doc AS

FDA 510(k) clearance K945940 for COATEST(R) APC(TM) RESISTANCE, Substantially Equivalent on 1995-08-07. Applicant: Axis-Shield Doc AS. Device class: 2.

Clearance details

Applicant: Axis-Shield Doc AS
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1994-12-05
Decision date: 1995-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.