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510(k) K120439

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG by Bio-Rad Laboratories, Inc. — Product Code LIP

K120439 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "BIOPLEX 2200 EBV IGG AND SYPHILIS IGG". The FDA issued a decision of Substantially Equivalent on March 14, 2012. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2012
Date Received
February 13, 2012
Clearance Type
Special
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

Other clearances by Bio-Rad Laboratories, Inc.

  • K183446 — BioPlex 2200 Lyme Total (March 12, 2019)
  • K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System (February 13, 2019)
  • K180577 — BioPlex 2200 25-OH Vitamin D Kit (June 22, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K170509 — BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC I (May 19, 2017)
  • K170413 — BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator (May 11, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K161687 — D-10 Hemoglobin A1c Program (October 14, 2016)
  • K152679 — Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, (May 10, 2016)
  • DEN150058 — Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 (March 28, 2016)

Other clearances for product code LIP

  • K241427 — Access Syphilis (September 6, 2024)
  • K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack (August 28, 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)
  • 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)

FDA data resources