BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200— 510(k) K041658
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K041658 for BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200, Substantially Equivalent on 2004-12-20. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redmond, WA, US
Recent devices under product code LKJ
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view allRecalls naming K041658
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 K041658.
Data sourced from openFDA. This site is unofficial and independent of the FDA.