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510(k) K860354

SEPRACELL LYMPHOCYTE SEPARATION MEDIUM by Sepratech Corporation C/O Keller and Heckman — Product Code JCF

K860354 is an FDA 510(k) premarket notification submitted by Sepratech Corporation C/O Keller and Heckman for the device "SEPRACELL LYMPHOCYTE SEPARATION MEDIUM". The FDA issued a decision of Substantially Equivalent on April 18, 1986. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1986
Date Received
January 30, 1986
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 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)
  • 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