CRYOCHECK WEAK LUPUS POSITIVE CONTROL— 510(k) K032804

Name: FDA 510(k) clearance K032804
Creator: U.S. Food and Drug Administration
Published: 2003-11-03

Substantially Equivalent

Precision Biologic

FDA 510(k) clearance K032804 for CRYOCHECK WEAK LUPUS POSITIVE CONTROL, Substantially Equivalent on 2003-11-03. Applicant: Precision Biologic. Device class: 2.

Clearance details

Applicant: Precision Biologic
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2003-09-09
Decision date: 2003-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartmouth, N.S., CA

Download summary PDF View on FDA.gov ↗

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