510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840799Substantially Equivalent

V.d.t.-Gonorrhea Test Kit

M.G. Laboratories, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840799 is the FDA 510(k) clearance record for V.D.T.-GONORRHEA TEST KIT, a class I device, cleared for M.G. Laboratories, Inc. on under FDA product code LIO (Device, Specimen Collection). FDA records list one 510(k) clearance for M.G. Laboratories, Inc. As of , FDA records show no recalls naming K840799.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
M.G. Laboratories, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LIO

Trailing 12 months

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

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