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510(k) K902445

LYMPHO SEP(TM) by Icn Biomedicals, Inc. — Product Code JCF

K902445 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "LYMPHO SEP(TM)". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
June 1, 1990
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 Icn Biomedicals, Inc.

  • K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (June 13, 2003)
  • K023252 — RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (November 22, 2002)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)
  • K922944 — IMMUCHEM LH-MW ELISA (February 2, 1993)
  • K922715 — IMMUCHEM PRL-MW ELISA (October 5, 1992)
  • K922376 — ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (October 5, 1992)
  • K920442 — IMMUCHEM TSH-MW ELISA (March 18, 1992)
  • K913963 — IMMUCHEM NEONATAL TSH-MP ELISA (December 13, 1991)
  • K885198 — 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (February 23, 1989)
  • K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (May 27, 1988)

Other clearances for product code JCF

  • K911731 — LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (December 15, 1992)
  • 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)
  • 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