BIOCLOT APC SENSITIVITY— 510(k) K983898

Substantially Equivalent

Biopool Intl., Inc.

FDA 510(k) clearance K983898 for BIOCLOT APC SENSITIVITY, Substantially Equivalent on 1999-01-06. Applicant: Biopool Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biopool Intl., Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1998-11-03
Decision date: 1999-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, 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.