BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM— 510(k) K093954
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K093954 for BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, Substantially Equivalent on 2010-08-24. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code NHX
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
Recent devices under product code NHX
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- K110296 — AXIS-SHIELD ANTI-CCP
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Recalls naming K093954
K-number listed on FDA's recall record- Z-1377-2023 — BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
- Z-1378-2023 — BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093954.
Data sourced from openFDA. This site is unofficial and independent of the FDA.