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510(k) K962423

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

K962423 is an FDA 510(k) premarket notification submitted by Becton Dickinson Microbiology Systems for the device "BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM". The FDA issued a decision of Substantially Equivalent on August 2, 1996. The device falls under product code JST (Kit, Fastidious Organisms), a Class I device regulated under 21 CFR 866.2660. Becton Dickinson Microbiology Systems has at least 10 other 510(k) clearances on record.

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

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)
  • 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)
  • K832051 — RIM-HAEMOPHILUS 1 & 2 (August 12, 1983)
  • K832239 — RIM-HAEMOPHILUS 2 (August 12, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)

FDA data resources