510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864565Substantially Equivalent

Monabrite Cytomegalovirus (Cmv) Ifa Kit

Serono Diagnostics, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864565 is the FDA 510(k) clearance record for MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT, a class II device, cleared for Serono Diagnostics, Inc. on under FDA product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus). FDA records list 25 510(k) clearances for Serono Diagnostics, Inc., from to . As of , FDA records show no recalls naming K864565.

Clearance record

Decision date
Received
(92 days to decision)
Product code
GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Serono Diagnostics, Inc. 100 Longwater Cir., Norwell MA
Third party review
No

Clearances, product code GQH

Trailing 12 months

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

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