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510(k) K910487

VISUWELL SYPHILIS ANTIGEN by Adi Diagnostics, Inc. — Product Code LIP

K910487 is an FDA 510(k) premarket notification submitted by Adi Diagnostics, Inc. for the device "VISUWELL SYPHILIS ANTIGEN". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code LIP (Enzyme Linked Immunoabsorption Assay, Treponema Pallidum), a Class II device regulated under 21 CFR 866.3830. Adi Diagnostics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
February 6, 1991
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

Other clearances by Adi Diagnostics, Inc.

  • K900973 — VISUWELL(R) CHLAMYDIA (May 15, 1990)
  • K900338 — VISUWELL(R) REAGIN TEST (MODIFICATION) (April 10, 1990)
  • K890840 — VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT (March 27, 1989)

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)
  • 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)

FDA data resources