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510(k) K812411

IMMUNO-CELL IMMUNO-SEP KIT by Kallestad Laboratories, Inc. — Product Code JCF

K812411 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "IMMUNO-CELL IMMUNO-SEP KIT". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1981
Date Received
August 21, 1981
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 Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)

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)
  • K854093 — LEUCO PREP (November 12, 1985)
  • K842818 — CST (October 23, 1984)
  • K842146 — HISTOPAQUE-1077 (July 27, 1984)

FDA data resources