PRIMUS A1CARE ASSAY— 510(k) K062658

Substantially Equivalent

Primus Corp.

FDA 510(k) clearance K062658 for PRIMUS A1CARE ASSAY, Substantially Equivalent on 2007-11-26. Applicant: Primus Corp..

Clearance details

Applicant: Primus Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2006-09-06
Decision date: 2007-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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