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510(k) K854093

LEUCO PREP by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
October 7, 1985
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

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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)
  • K891407 — LEUCOPREP CELL SEPARATION TUBE (May 26, 1989)
  • 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)
  • K842818 — CST (October 23, 1984)
  • K842146 — HISTOPAQUE-1077 (July 27, 1984)
  • K812947 — MONO-POLY RESOLVING MEDIUM (March 11, 1982)