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510(k) K910487

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

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)

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  • K112343 — TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS (January 20, 2012)
  • K102400 — SYPHILIS HEALTH CHECK (August 1, 2011)