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510(k) K955136

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

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.

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  • 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)
  • 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)

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