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510(k) K170413

BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set by Bio-Rad Laboratories — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2017
Date Received
February 10, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

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  • K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG (March 14, 2012)
  • K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (January 20, 2012)
  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)
  • K102283 — ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM (February 10, 2011)