510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K832541Substantially Equivalent

Simplex-2

Gentech Australia, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832541 is the FDA 510(k) clearance record for SIMPLEX-2, a class II device, cleared for Gentech Australia on under FDA product code GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2). FDA records list one 510(k) clearance for Gentech Australia. As of , FDA records show no recalls naming K832541.

Clearance record

Decision date
Received
(190 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
Gentech Australia 803 N. Front St. Suite 3, Mchenry IL
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