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510(k) K913867

URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) by Immunalysis Corporation — Product Code KLN

K913867 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)". The FDA issued a decision of Substantially Equivalent on September 19, 1991. The device falls under product code KLN (Radioimmunoassay, Cocaine Metabolite), a Class II device regulated under 21 CFR 862.3250. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cocaine Metabolite
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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  • 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 KLN

  • K010868 — PSYCHEMEDICS RIA COCAINE ASSAY (November 6, 2001)
  • K913722 — ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (September 10, 1991)
  • K912756 — ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (July 26, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K910044 — MILENIA COCAINE METABOLITE (February 13, 1991)
  • K905730 — ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (January 15, 1991)
  • K904995 — ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (November 28, 1990)
  • K880674 — MICROMEDIC CRACKPOT RIA KIT (October 6, 1988)
  • K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (June 16, 1987)

FDA data resources