PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794— 510(k) K023857

Name: FDA 510(k) clearance K023857
Creator: U.S. Food and Drug Administration
Published: 2003-05-16

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K023857 for PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794, Substantially Equivalent on 2003-05-16. Applicant: Bio-Rad. Device class: 1.

Clearance details

Applicant: Bio-Rad
Product code: Code NOM
Device class: Class 1
Regulation: 21 CFR 866.3040
Advisory panel: Microbiology
Date received: 2002-11-20
Decision date: 2003-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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