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510(k) K910835

BACTEC NR-860 by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1991
Date Received
February 27, 1991
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

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Other clearances for product code JTA

  • K954923 — BACTEC FUNGAL MEDIUM (November 21, 1996)
  • 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)
  • K833917 — BAC-T-SCREEN (January 13, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (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)