TRIAGE PROFILER S.O.B. PANEL— 510(k) K040437

Name: FDA 510(k) clearance K040437
Creator: U.S. Food and Drug Administration
Published: 2004-06-25

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K040437 for TRIAGE PROFILER S.O.B. PANEL, Substantially Equivalent on 2004-06-25. Applicant: Biosite Incorporated. Device class: 2.

Clearance details

Applicant: Biosite Incorporated
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 2004-02-19
Decision date: 2004-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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