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510(k) K926018

CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM by Becton Dickinson Microbiology Systems — Product Code JSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1993
Date Received
November 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Identification, Enterobacteriaceae
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 JSS

  • K150031 — hemoFISH Masterpanel (October 1, 2015)
  • K123418 — GRAM-NEGATIVE QUICKFISH BC (July 21, 2013)
  • K101558 — GNR TRAFFIC LIGHT PNA FISH (December 16, 2010)
  • K092236 — E.COLI/P. AERUGINOSA PNA FISH (December 16, 2009)
  • K092393 — EK/P. AERUGINOSA PNA FISH (September 1, 2009)
  • K082068 — E. COLI PNA FISH (June 25, 2009)
  • K081433 — EK/P. AERUGINOSA PNA FISH (March 26, 2009)
  • K081309 — E.COLI/P. AERUGINOSA PNA FISH (December 19, 2008)
  • K926002 — ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (September 23, 1993)
  • K924814 — API 20E/UNISCEPT 20E (March 11, 1993)