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510(k) K855071

IMIPENEM SUSCEPTIBILITY POWDER by Merck, Sharp & Dohme — Product Code JTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
December 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Powders, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Merck, Sharp & Dohme

  • K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (May 4, 1988)
  • K864442 — NORFLOXACIN SUSCEPTIBILITY POWDER (December 11, 1986)
  • K760605 — LIGHTCAST II CARBIDE BLADE (October 5, 1976)

Other clearances for product code JTT

  • K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN (December 17, 1998)
  • K935805 — PASCO MIC AND MIC/ID PANELS (June 13, 1994)
  • K895362 — BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST (December 1, 1989)
  • K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER (May 4, 1988)
  • K872081 — CIPRO (TM) DIAGNOSTIC POWDER (June 15, 1987)
  • K864442 — NORFLOXACIN SUSCEPTIBILITY POWDER (December 11, 1986)
  • K855106 — IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (March 6, 1986)
  • K855207 — IMIPENEM 10 MCG SENSITIVITY DISCS (March 6, 1986)
  • K860031 — GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (March 6, 1986)
  • K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (May 25, 1983)