Home / 510(k) Clearances / K961046

510(k) K961046

10B ARGININE BROTH by Remel, L.P. — Product Code JSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1996
Date Received
March 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
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)
  • K955143 — RPR LIQUID CONTROLS (July 30, 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 JSM

  • K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport De (November 26, 2025)
  • K250205 — Babio® Virus Transport Kit (Non-inactivating) (September 22, 2025)
  • K242576 — AllTest Viral Transport Medium (April 4, 2025)
  • K232565 — UriSponge™ (October 11, 2024)
  • K220908 — Ensol EnTM Specimen Collection and Transport System (August 29, 2024)
  • K240235 — OmniTrans Transport System (August 19, 2024)
  • K233534 — Viral Transport Medium (August 2, 2024)
  • K233449 — Avantik VTM (July 15, 2024)
  • K232454 — Viral Transport Media (VTM) (May 3, 2024)
  • K232357 — Copan Universal Transport Medium (UTM-RT) System (April 25, 2024)