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FDA 510(k), K043341, BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA 510(k), K043341, BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
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510(K) Number: K043341
Device Name: BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Manufacturer: BIO-RAD LABORATORIES, INC.
Device Classification Name: diagnostic software, k-nearest neighbor algorithm, autoimmune disease
Regulation Number: 862.3100
Classification Product Code: NVI
Date Received: 12/03/2004
Decision Date: 10/27/2005
Regulation Medical Specialty: Toxicology
Device Name: BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Manufacturer: BIO-RAD LABORATORIES, INC.
Device Classification Name: diagnostic software, k-nearest neighbor algorithm, autoimmune disease
Regulation Number: 862.3100
Classification Product Code: NVI
Date Received: 12/03/2004
Decision Date: 10/27/2005
Regulation Medical Specialty: Toxicology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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