510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955608Substantially Equivalent

Mccoy Cell Cultures

Vai Diagnostics, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955608 is the FDA 510(k) clearance record for MCCOY CELL CULTURES, a class I device, cleared for Vai Diagnostics, Inc. on under FDA product code KIR (Cells, Animal And Human, Cultured). FDA records list one 510(k) clearance for Vai Diagnostics, Inc. As of , FDA records show no recalls naming K955608.

Clearance record

Decision date
Received
(213 days to decision)
Product code
KIR Cells, Animal And Human, Cultured
Regulation
21 CFR 864.2280
Device class
Class I
Review panel
Hematology
Applicant
Vai Diagnostics, Inc. 5171 Wilfong Rd., Memphis TN
510(k) summary
Statement
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