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510(k) K962423

BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM by Becton Dickinson Microbiology Systems — Product Code JST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1996
Date Received
June 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Fastidious Organisms
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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  • 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)
  • K972098 — FOSFOMYCIN, 200 MG, SENSI-DISC (July 28, 1997)
  • K970385 — SPARFLOZACIN, 5 MCG, SENSI-DISC (March 10, 1997)

Other clearances for product code JST

  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)
  • K841661 — SYNTHETIC BROTH A.O.A.C. (May 11, 1984)
  • K832239 — RIM-HAEMOPHILUS 2 (August 12, 1983)
  • K832051 — RIM-HAEMOPHILUS 1 & 2 (August 12, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)