BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM— 510(k) K062211

Name: FDA 510(k) clearance K062211
Creator: U.S. Food and Drug Administration
Published: 2006-12-08

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K062211 for BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, Substantially Equivalent on 2006-12-08. Applicant: Bio-Rad Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Product code LSE
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 2006-08-01
Decision date: 2006-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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