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510(k) K871117

TB QUICK STAIN(TM) KIT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code ICJ

K871117 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "TB QUICK STAIN(TM) KIT". The FDA issued a decision of Substantially Equivalent on April 3, 1987. The device falls under product code ICJ (Carbol Night Blue), a Class I device regulated under 21 CFR 864.1850. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1987
Date Received
March 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carbol Night Blue
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Bd Becton Dickinson Vacutainer Systems Preanalytic

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

FDA data resources