PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM— 510(k) K091052

Name: FDA 510(k) clearance K091052
Creator: U.S. Food and Drug Administration
Published: 2010-01-15

Substantially Equivalent

Abaxis, Inc.

FDA 510(k) clearance K091052 for PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM, Substantially Equivalent on 2010-01-15. Applicant: Abaxis, Inc.. Device class: 2.

Clearance details

Applicant: Abaxis, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2009-04-13
Decision date: 2010-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Union City, CA, US

Download summary PDF View on FDA.gov ↗

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