Home / 510(k) Clearances / K952802

510(k) K952802

VISUWELL REAGIN II by Biomira Diagnostics, Inc. — Product Code GMQ

K952802 is an FDA 510(k) premarket notification submitted by Biomira Diagnostics, Inc. for the device "VISUWELL REAGIN II". The FDA issued a decision of Substantially Equivalent on May 23, 1996. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Biomira Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
June 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Biomira Diagnostics, Inc.

  • K932453 — VISUWELL SYPHILIS ANTIBODY (July 11, 1995)

Other clearances for product code GMQ

  • K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test (October 10, 2025)
  • K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Ev (October 21, 2020)
  • K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (November 30, 2018)
  • K173376 — ASI Evolution (June 14, 2018)
  • K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Syste (November 12, 2015)
  • K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (June 12, 2000)
  • K993633 — SYNTHETIC VDRL ANTIGEN (February 23, 2000)
  • K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI (September 20, 1999)
  • K954994 — TRUST (October 18, 1996)
  • K955136 — RPR CARD TEST KIT (July 29, 1996)

FDA data resources