BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

BIO-RAD LABORATORIES, INC. · K043341 · 2005-10-27

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM is an AI-enabled medical device from BIO-RAD LABORATORIES, INC., listed by FDA (510(k), K043341) with a decision date of 2005-10-27. Review panel: Clinical Toxcicology.

FDA submission numberK043341
Pathway510(k)
CompanyBIO-RAD LABORATORIES, INC.
Review panel (specialty)Clinical Toxcicology
FDA decision date2005-10-27
DecisionSubstantially Equivalent
Product codeNVI
ClassificationDiagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
Device class2
Regulation number862.3100
Review time (calendar days)328
Applicant countryUS

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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.