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
K830865Substantially Equivalent

Hsv Igm Test

Gull Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830865 is the FDA 510(k) clearance record for HSV IGM TEST, a class II device, cleared for Gull Laboratories, Inc. on under FDA product code GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2). FDA records list 57 510(k) clearances for Gull Laboratories, Inc., from to . As of , FDA records show no recalls naming K830865.

Clearance record

Decision date
Received
(122 days to decision)
Product code
GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2
Regulation
21 CFR 866.3305
Device class
Class II
Review panel
Microbiology
Applicant
Gull Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GQL

Trailing 12 months

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

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