510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791948Substantially Equivalent

Fiax Test Kit for Anti-Cytomegalorirus

Intl. Diagnostic Technology, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791948 is the FDA 510(k) clearance record for FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS, a class II device, cleared for Intl. Diagnostic Technology on under FDA product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus). FDA records list 29 510(k) clearances for Intl. Diagnostic Technology, from to . As of , FDA records show no recalls naming K791948.

Clearance record

Decision date
Received
(46 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
Intl. Diagnostic Technology 803 N. Front St. Suite 3, Mchenry IL
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