510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854974Substantially Equivalent

Hsv Idr

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

K854974 is the FDA 510(k) clearance record for HSV IDR, a class II device, cleared for Genus Diagnostics on under FDA product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2). FDA records list 9 510(k) clearances for Genus Diagnostics, from to . As of , FDA records show no recalls naming K854974.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Genus Diagnostics 225 Wildwood St., Woburn MA
Third party review
No

Clearances, product code GQN

Trailing 12 months

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

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