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510(k) K010537

LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC by Oxoid , Ltd. — Product Code JTN

K010537 is an FDA 510(k) premarket notification submitted by Oxoid , Ltd. for the device "LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC". The FDA issued a decision of Substantially Equivalent on April 24, 2001. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Oxoid , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
February 23, 2001
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 Oxoid , Ltd.

  • K070262 — ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 14, 2007)
  • K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (March 17, 2006)
  • K042157 — DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (September 14, 2004)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M (December 10, 2001)
  • K010536 — MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 24, 2001)
  • K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 22, 2000)
  • K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (May 15, 2000)
  • K993401 — DRYSPOT E.COLI 0157 KIT (February 28, 2000)
  • K984513 — TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (April 2, 1999)

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