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510(k) K855071

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

K855071 is an FDA 510(k) premarket notification submitted by Merck, Sharp & Dohme for the device "IMIPENEM SUSCEPTIBILITY POWDER". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code JTT (Susceptibility Test Powders, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Merck, Sharp & Dohme has at least 3 other 510(k) clearances on record.

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)
  • K855207 — IMIPENEM 10 MCG SENSITIVITY DISCS (March 6, 1986)
  • K855106 — IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (March 6, 1986)
  • K860031 — GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (March 6, 1986)
  • K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (May 25, 1983)

FDA data resources