MINIQUANT D-DIMER, MODEL 1447— 510(k) K002642

Name: FDA 510(k) clearance K002642
Creator: U.S. Food and Drug Administration
Published: 2001-02-05

Substantially Equivalent

Biopool Intl., Inc.

FDA 510(k) clearance K002642 for MINIQUANT D-DIMER, MODEL 1447, Substantially Equivalent on 2001-02-05. Applicant: Biopool Intl., Inc.. Device class: 2.

Clearance details

Applicant: Biopool Intl., Inc.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2000-08-24
Decision date: 2001-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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