510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860354Substantially Equivalent

Sepracell Lymphocyte Separation Medium

Sepratech Corporation C/O Keller and Heckman, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860354 is the FDA 510(k) clearance record for SEPRACELL LYMPHOCYTE SEPARATION MEDIUM, a class I device, cleared for Sepratech Corporation C/O Keller and Heckman on under FDA product code JCF (Lymphocyte Separation Medium). FDA records list one 510(k) clearance for Sepratech Corporation C/O Keller and Heckman. As of , FDA records show no recalls naming K860354.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JCF Lymphocyte Separation Medium
Regulation
21 CFR 864.8500
Device class
Class I
Review panel
Hematology
Applicant
Sepratech Corporation C/O Keller and Heckman 1150 17th St., NW, Washington DC
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