510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812411Substantially Equivalent

Immuno-Cell Immuno-Sep Kit

Kallestad Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812411 is the FDA 510(k) clearance record for IMMUNO-CELL IMMUNO-SEP KIT, a class I device, cleared for Kallestad Laboratories, Inc. on under FDA product code JCF (Lymphocyte Separation Medium). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K812411.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JCF Lymphocyte Separation Medium
Regulation
21 CFR 864.8500
Device class
Class I
Review panel
Hematology
Applicant
Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JCF

Trailing 12 months

FDA records hold no clearances under product code JCF in the trailing twelve months.

FDA records show no clearances under product code JCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JCF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260