510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963425Substantially Equivalent

Genzyme Diagnostics Contrast Mono

Sekisui Diagnostics, LLC, San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963425 is the FDA 510(k) clearance record for GENZYME DIAGNOSTICS CONTRAST MONO, a class II device, cleared for Genzyme Diagnostics on under FDA product code KTN (System, Test, Infectious Mononucleosis). FDA records list 21 510(k) clearances for Sekisui Diagnostics, LLC, from to . As of , FDA records show no recalls naming K963425.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KTN System, Test, Infectious Mononucleosis
Regulation
21 CFR 866.5640
Device class
Class II
Review panel
Immunology
Applicant
Genzyme Diagnostics 1531 Industrial Rd., San Carlos CA
510(k) summary
Summary
Third party review
No

Clearances, product code KTN

Trailing 12 months

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

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