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510(k) K241534

VITROS Immunodiagnostic Products Syphilis Reagent Pack by Ortho Clinical Diagnostics — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2024
Date Received
May 30, 2024
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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Other clearances for product code LIP

  • K241427 — Access Syphilis (September 6, 2024)
  • K211302 — Elecsys Syphilis (July 20, 2021)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K160910 — Elecsys Syphilis (July 28, 2016)
  • K153145 — Lumipulse G TP-N Immunoreaction Cartridge Set (July 5, 2016)
  • K153730 — ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphi (June 15, 2016)
  • 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)