Home / 510(k) Clearances / K140671

510(k) K140671

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE by Omega Laboratories, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
March 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Omega Laboratories, Inc.

  • K142855 — Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-me (July 28, 2015)
  • K131128 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (November 13, 2013)
  • K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE (June 25, 2013)
  • K122759 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) (December 5, 2012)
  • K112808 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES (January 23, 2012)
  • K103161 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES (December 13, 2011)
  • K101973 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENE (August 16, 2011)
  • K101059 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE (July 12, 2010)

Other clearances for product code DJG

  • K252684 — Labcorp Fentanyl Urine Visual Test (January 29, 2026)
  • K250741 — Evidence MultiSTAT DOA Urine MultiPlex (January 23, 2026)
  • K253082 — LZI Buprenorphine II Enzyme Immunoassay (January 16, 2026)
  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative (August 15, 2025)
  • K251634 — LZI Fentanyl III Enzyme Immunoassay (June 18, 2025)
  • K240124 — BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader (June 14, 2024)
  • K240698 — Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
  • K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard (March 8, 2024)
  • K232228 — Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug (February 23, 2024)