BIOPLEX 2200 APLS IGM— 510(k) K130528
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K130528 for BIOPLEX 2200 APLS IGM, Substantially Equivalent on 2013-10-21. 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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Recalls naming K130528
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130528.
Data sourced from openFDA. This site is unofficial and independent of the FDA.