BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM— 510(k) K092587
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K092587 for BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM, Substantially Equivalent on 2010-12-03. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code LFX
- Device class
- Class 2
- Regulation
- 21 CFR 866.3510
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
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