CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST— 510(k) K881068

Name: FDA 510(k) clearance K881068
Creator: U.S. Food and Drug Administration
Published: 1988-03-23

Substantially Equivalent

Creative Laboratory Products, Inc.

FDA 510(k) clearance K881068 for CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST, Substantially Equivalent on 1988-03-23. Applicant: Creative Laboratory Products, Inc.. Device class: 2.

Clearance details

Applicant: Creative Laboratory Products, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1988-03-14
Decision date: 1988-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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