AUTODIMER ASSAY MODEL # 1431— 510(k) K012755

Substantially Equivalent

Xtrana, Inc.

FDA 510(k) clearance K012755 for AUTODIMER ASSAY MODEL # 1431, Substantially Equivalent on 2002-03-15. Applicant: Xtrana, Inc.. Device class: 2.

Clearance details

Applicant: Xtrana, Inc.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2001-08-16
Decision date: 2002-03-15
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.