BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS— 510(k) K103834
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K103834 for BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS, Substantially Equivalent on 2012-03-30. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
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