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510(k) K872081

CIPRO (TM) DIAGNOSTIC POWDER by Miles Pharmaceuticals — Product Code JTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1987
Date Received
May 29, 1987
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 Miles Pharmaceuticals

  • K820578 — MEZLIN DIAGNOSTIC REAGENT (May 12, 1982)

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  • 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)
  • 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)
  • K855071 — IMIPENEM SUSCEPTIBILITY POWDER (March 6, 1986)
  • K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (May 25, 1983)