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510(k) K891407

LEUCOPREP CELL SEPARATION TUBE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JCF

K891407 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "LEUCOPREP CELL SEPARATION TUBE". The FDA issued a decision of Substantially Equivalent on May 26, 1989. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1989
Date Received
March 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lymphocyte Separation Medium
Device Class
Class I
Regulation Number
864.8500
Review Panel
HE
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)

Other clearances for product code JCF

  • K911731 — LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (December 15, 1992)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K874328 — L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA (February 16, 1988)
  • K873185 — DYNABEADS HLA CELL PREP II ISOLATION PRODUCT (November 4, 1987)
  • K872775 — LEUCOPREP BRAND TUBE (October 2, 1987)
  • K860354 — SEPRACELL LYMPHOCYTE SEPARATION MEDIUM (April 18, 1986)
  • K854093 — LEUCO PREP (November 12, 1985)
  • K842818 — CST (October 23, 1984)
  • K842146 — HISTOPAQUE-1077 (July 27, 1984)
  • K812947 — MONO-POLY RESOLVING MEDIUM (March 11, 1982)

FDA data resources