CARESIDE APTT— 510(k) K014028

Substantially Equivalent

Careside Hemotology, Inc.

FDA 510(k) clearance K014028 for CARESIDE APTT, Substantially Equivalent on 2002-02-08. Applicant: Careside Hemotology, Inc.. Device class: 2.

Clearance details

Applicant: Careside Hemotology, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2001-12-06
Decision date: 2002-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, 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.