510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040327Substantially Equivalent

Accu-Stat Home Drug Tests for Marijuana (Thc) and for Marijuana & Cocaine (Thc, Coc)

Accu-Stat Diagnostics, Inc., Lake Forest CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040327 is the FDA 510(k) clearance record for ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC), cleared for Accu-Stat Diagnostics, Inc. on under FDA product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter). FDA records list 3 510(k) clearances for Accu-Stat Diagnostics, Inc., from to . As of , FDA records show no recalls naming K040327.

Clearance record

Decision date
Received
(69 days to decision)
Product code
MVO Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device class
Unclassified
Review panel
Unknown
Applicant
Accu-Stat Diagnostics, Inc. 11 Orchard Rd., Suite 108, Lake Forest CA
510(k) summary
Summary PDF
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