Home / 510(k) Clearances / K161714

510(k) K161714

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2016
Date Received
June 21, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

Other clearances by Immunalysis Corporation

  • K252520 — SEFRIA™ Hydrocodone Oral Fluid (September 11, 2025)
  • K232898 — Quantisal™ Oral Fluid Collection Device (November 21, 2023)
  • K223781 — Quantisal™ II Oral Fluid Collection Device (July 28, 2023)
  • K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K203489 — SEFRIA PCP Oral Fluid Enzyme Immunoassay (April 20, 2021)
  • K200801 — Quantisal Oral Fluid Collection Device (July 28, 2020)
  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
  • K181135 — Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay (January 24, 2019)

Other clearances for product code DIS

  • K151211 — AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbit (June 4, 2015)
  • K150791 — Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphin (April 24, 2015)
  • K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone (January 13, 2015)
  • K140665 — GenPrime Snap-Top Split Key Cup (December 8, 2014)
  • K140215 — ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD (June 16, 2014)
  • K092268 — RANDOX BARITURATES ASSAY (May 25, 2011)
  • K110515 — UCP DRUG SCREENING TEST CUPS (April 20, 2011)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT (January 5, 2007)