BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set

Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

Bio-Rad Laboratories

The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Bioplex 2200 Syphilis Total & Rpr, Bioplex 2200 Syphilis Total & Rpr Calibrator Set, Bioplex 2200 Syphilis Total & Rpr Control Set.

Pre-market Notification Details

Device IDK170413
510k NumberK170413
Device Name:BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
ClassificationEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant Bio-Rad Laboratories 5500 E. 2nd Street Benicia,  CA  94510
ContactJuang Wang
CorrespondentJuang Wang
Bio-Rad Laboratories 5500 E. 2nd Street Benicia,  CA  94510
Product CodeLIP  
Subsequent Product CodeGMQ
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-10
Decision Date2017-05-11
Summary:summary

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