TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A— 510(k) K974881

Name: FDA 510(k) clearance K974881
Creator: U.S. Food and Drug Administration
Published: 1998-03-20

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K974881 for TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A, Substantially Equivalent on 1998-03-20. Applicant: Biosite Incorporated. Device class: 1.

Clearance details

Applicant: Biosite Incorporated
Product code: Code MCB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1997-12-30
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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