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510(k) K955143

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

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)
  • K961819 — STREPTOMYCIN DISK (300MCG) (July 10, 1996)
  • K961818 — GENTAMICIN DISK (120MCG) (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)