510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013778Substantially Equivalent

Peace of Mind Home Drug Test

Advantage Diagnostics Corp., Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013778 is the FDA 510(k) clearance record for PEACE OF MIND HOME DRUG TEST, cleared for Advantage Diagnostics Corp. on under FDA product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter). FDA records list 10 510(k) clearances for Advantage Diagnostics Corp., from to . As of , FDA records show no recalls naming K013778.

Clearance record

Decision date
Received
(86 days to decision)
Product code
MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device class
Unclassified
Review panel
Unknown
Applicant
Advantage Diagnostics Corp. 1201 Douglas Ave., Redwood City CA
510(k) summary
Summary
Third party review
No

Clearances, product code MVO

Trailing 12 months

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

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