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510(k) K961818

GENTAMICIN DISK (120MCG) by Remel, L.P. — Product Code JTN

K961818 is an FDA 510(k) premarket notification submitted by Remel, L.P. for the device "GENTAMICIN DISK (120MCG)". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Remel, L.P. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1996
Date Received
May 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
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)
  • K955136 — RPR CARD TEST KIT (July 29, 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 JTN

  • K260842 — HardyDisk AST Gepotidacin 10µg (GEP10) (May 11, 2026)
  • K251337 — Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 (December 5, 2025)
  • K253105 — HardyDisk AST Cefiderocol 30µg (FDC30) (November 20, 2025)
  • K251879 — Sulopenem SPM 2 µg (August 12, 2025)
  • K250956 — HardyDisk AST Gepotidacin 10µg (GEP10) (June 26, 2025)
  • K250885 — Ceftobiprole BPR 5 µg Disc (June 23, 2025)
  • K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (June 12, 2025)
  • K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) (May 15, 2025)
  • K241060 — HardyDisk AST Cefiderocol 30µg (FDC30) (July 18, 2024)
  • K231806 — Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 (March 22, 2024)

FDA data resources