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510(k) K955136

RPR CARD TEST KIT by Remel, L.P. — Product Code GMQ

K955136 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "RPR CARD TEST KIT". The FDA issued a decision of Substantially Equivalent on July 29, 1996. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Remel, L.P. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1996
Date Received
November 13, 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 Remel, L.P.

  • K972359 — REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN (August 28, 1997)
  • K964315 — REMEL STAPH LATEX KIT (February 7, 1997)
  • K964421 — REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK (December 6, 1996)
  • K961046 — 10B ARGININE BROTH (September 18, 1996)
  • K955143 — RPR LIQUID CONTROLS (July 30, 1996)
  • K961818 — GENTAMICIN DISK (120MCG) (July 10, 1996)
  • K961819 — STREPTOMYCIN DISK (300MCG) (July 10, 1996)
  • K960313 — MUELLER HINTON AGAR WITH 2% NACI (March 25, 1996)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)

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)
  • K952802 — VISUWELL REAGIN II (May 23, 1996)

FDA data resources