510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851928Substantially Equivalent

Hek Gencells

Genus Diagnostics, Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851928 is the FDA 510(k) clearance record for HEK GENCELLS, a class I device, cleared for Genus Diagnostics on under FDA product code KIR (Cells, Animal And Human, Cultured). FDA records list 9 510(k) clearances for Genus Diagnostics, from to . As of , FDA records show no recalls naming K851928.

Clearance record

Decision date
Received
(18 days to decision)
Product code
KIR Cells, Animal And Human, Cultured
Regulation
21 CFR 864.2280
Device class
Class I
Review panel
Hematology
Applicant
Genus Diagnostics 225 Wildwood St., Woburn MA
Third party review
No

Clearances, product code KIR

Trailing 12 months

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

FDA records show no clearances under product code KIR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KIR, 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