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510(k) K983310

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN by Accumed Intl., Inc. — Product Code JTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1998
Date Received
September 21, 1998
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 Accumed Intl., Inc.

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  • K983306 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN (December 18, 1998)
  • K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN (December 14, 1998)
  • K983301 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN (November 25, 1998)
  • K982786 — TRACCELL 2000 SLIDE MAPPING SYSTEM (October 16, 1998)
  • K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (January 22, 1998)
  • K964689 — TRACCELL 2000 SLIDE MAPPING SYSTEM (August 18, 1997)
  • K972756 — MODIFICATION OF EST CULTURE SYSTEM II - MYCO (August 1, 1997)
  • K965190 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE (March 19, 1997)
  • K960366 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES (April 9, 1996)

Other clearances for product code JTT

  • 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)
  • K860031 — GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK (March 6, 1986)
  • K855207 — IMIPENEM 10 MCG SENSITIVITY DISCS (March 6, 1986)
  • K855106 — IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 (March 6, 1986)
  • K855071 — IMIPENEM SUSCEPTIBILITY POWDER (March 6, 1986)
  • K830758 — AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (May 25, 1983)