510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101973Substantially Equivalent

Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma)

Omega Laboratories, Inc., South Lyon MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101973 is the FDA 510(k) clearance record for OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA), a class II device, cleared for Omega Laboratories, Inc. on under FDA product code LAF (Gas Chromatography, Methamphetamine). FDA records list 9 510(k) clearances for Omega Laboratories, Inc., from to . As of , FDA records show no recalls naming K101973.

Clearance record

Decision date
Received
(399 days to decision)
Product code
LAF Gas Chromatography, Methamphetamine
Regulation
21 CFR 862.3610
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Omega Laboratories, Inc. P.O. Box 506, South Lyon MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LAF

Trailing 12 months

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

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