Home / 510(k) Clearances / K955143

510(k) K955143

RPR LIQUID CONTROLS by Remel, L.P. — Product Code GMP

K955143 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "RPR LIQUID CONTROLS". The FDA issued a decision of Substantially Equivalent on July 30, 1996. The device falls under product code GMP (Antisera, Control For Nontreponemal Tests), 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 30, 1996
Date Received
November 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Control For Nontreponemal Tests
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)
  • K955136 — RPR CARD TEST KIT (July 29, 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 GMP

  • K980638 — ADI SYPHILIS RPR LIQUID CONTROLS (July 6, 1998)
  • K961998 — QUALITROL SYPHSERO CONTROL SET (August 8, 1996)
  • K885298 — VISUWELL REAGIN TEST 960 TEST KIT (March 15, 1989)
  • K875180 — V-TREND RPRL CARD TEST (February 4, 1988)
  • K851504 — VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 (August 19, 1985)
  • K843741 — RPR TEST REDITEST (October 25, 1984)
  • K812425 — BECKMAN R.PR CONTROL SERUM SET (September 23, 1981)
  • K810119 — CONTROL SERUMS FOR NONTREPONEMAL TEST (February 9, 1981)

FDA data resources