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510(k) K972098

FOSFOMYCIN, 200 MG, SENSI-DISC by Becton Dickinson Microbiology Systems — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1997
Date Received
June 4, 1997
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 Becton Dickinson Microbiology Systems

  • K993577 — CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, (December 1, 1999)
  • K984631 — BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSA (November 4, 1999)
  • K981517 — CEFDINIR, 5 UG, SENSI-DISC (June 9, 1998)
  • K980683 — TROVAFLOXACIN 10G, SENSI-DISC (May 1, 1998)
  • K974578 — GREPAFLOXACIN, 5 MG, SENSI-DISC (February 23, 1998)
  • K970333 — BACTEC MYCO/F LYTIC CULTURE VIALS (January 28, 1998)
  • K970512 — BACTEC MYCO/F LYTIC CULTURE VIALS (January 8, 1998)
  • K972758 — BACTEC MYCO/F-SPUTA CULTURE VIALS (August 8, 1997)
  • K970385 — SPARFLOZACIN, 5 MCG, SENSI-DISC (March 10, 1997)
  • K970212 — LEVOFLOXACIN, 5MCG, SENSI-DISC (March 6, 1997)

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