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510(k) K954923

BACTEC FUNGAL MEDIUM by Becton Dickinson Diagnostic Instrument Systems — Product Code JTA

K954923 is an FDA 510(k) premarket notification submitted by Becton Dickinson Diagnostic Instrument Systems for the device "BACTEC FUNGAL MEDIUM". The FDA issued a decision of Substantially Equivalent on November 21, 1996. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Becton Dickinson Diagnostic Instrument Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1996
Date Received
October 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Microbial Growth
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type

Other clearances by Becton Dickinson Diagnostic Instrument Systems

  • K954932 — BBL MGIT PRODUCTS (August 21, 1996)
  • K962210 — BACTEC 9050 SYSTEM (August 8, 1996)
  • K946268 — BACTEC(R) 9000TB SYSTEM (May 21, 1996)
  • K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571) (May 17, 1996)
  • K954925 — BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (February 16, 1996)
  • K954921 — BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS (February 16, 1996)
  • K954927 — BACTEC PEDS PLUS/F CULTURE VIALS (February 16, 1996)
  • K954930 — BACTEC CULTURE VIALS, LYTIC, ANAEROBIC (February 16, 1996)
  • K954924 — BACTEC PEDS PLUS CLUTURE VIALS (February 8, 1996)
  • K955504 — QBC ACCUREAD SYSTEM (February 5, 1996)

Other clearances for product code JTA

  • K910835 — BACTEC NR-860 (March 11, 1991)
  • K865021 — BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (February 6, 1987)
  • K853011 — BACTEC NR-730 BACTERIAL DETECTION SYSTEM (July 30, 1985)
  • K842874 — RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (September 12, 1984)
  • K842279 — BECTEC NR-660 BACTERIAL DETECT SYS (July 20, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (January 13, 1984)
  • K833917 — BAC-T-SCREEN (January 13, 1984)
  • K810042 — BACTEC BACTERIAL DETECTION SYSTEM: #5 (January 28, 1981)
  • K792575 — BACTEC BACTERIAL DETECTION SYSTEM (December 27, 1979)
  • K790297 — DETECTION SYSTEM, MS-2 ELECTROCHEMICAL (April 26, 1979)

FDA data resources