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510(k) K910835

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

K910835 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC NR-860". The FDA issued a decision of Substantially Equivalent on Mar 11, 1991. The device falls under product code JTA (Monitor, Microbial Growth), a Class I device regulated under 21 CFR 866.2560. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 11, 1991
Date Received
Feb 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

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (Jun 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (Mar 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (Feb 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (Nov 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (Jun 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (Nov 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (Oct 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (Sep 23, 1999)

Other clearances for product code JTA

  • K954923 — BACTEC FUNGAL MEDIUM (Nov 21, 1996)
  • K865021 — BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (Feb 6, 1987)
  • K853011 — BACTEC NR-730 BACTERIAL DETECTION SYSTEM (Jul 30, 1985)
  • K842874 — RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (Sep 12, 1984)
  • K842279 — BECTEC NR-660 BACTERIAL DETECT SYS (Jul 20, 1984)
  • K833917 — BAC-T-SCREEN (Jan 13, 1984)
  • K834264 — REVERSE-FLOW SYSTEM (Jan 13, 1984)
  • K810042 — BACTEC BACTERIAL DETECTION SYSTEM: #5 (Jan 28, 1981)
  • K792575 — BACTEC BACTERIAL DETECTION SYSTEM (Dec 27, 1979)
  • K790297 — DETECTION SYSTEM, MS-2 ELECTROCHEMICAL (Apr 26, 1979)

FDA data resources