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510(k) K984631

BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY by Becton Dickinson Microbiology Systems — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1999
Date Received
December 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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  • K974578 — GREPAFLOXACIN, 5 MG, SENSI-DISC (February 23, 1998)
  • K970333 — BACTEC MYCO/F LYTIC CULTURE VIALS (January 28, 1998)
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  • 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)
  • K970212 — LEVOFLOXACIN, 5MCG, SENSI-DISC (March 6, 1997)

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  • K140887 — COBAS CT/NG V2.0 TEST (May 5, 2014)
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