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510(k) K820903

THC-CANNABINOIDS DIRECT URINE RIA KIT by Immunalysis Corporation — Product Code LAT

K820903 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "THC-CANNABINOIDS DIRECT URINE RIA KIT". The FDA issued a decision of Substantially Equivalent on May 5, 1982. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Immunalysis Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
March 31, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cannabinoid(S)
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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  • K190397 — Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA (November 15, 2019)
  • K183048 — Quantisal II Oral Fluid Collection Device (July 29, 2019)
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Other clearances for product code LAT

  • K011426 — PSYCHEMEDICS RIA CANNABINOID ASSAY (May 3, 2002)
  • K961620 — ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (June 13, 1996)
  • K936135 — SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRAT (June 10, 1996)
  • K914507 — DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (December 18, 1991)
  • K913414 — ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (September 25, 1991)
  • K913865 — URINE THC DIRECT RIA KIT (I-125) (September 18, 1991)
  • K912574 — ABUSCREEN ONLINE FOR THC (50 AND 100) (August 12, 1991)
  • K904996 — ABUSCREEN ONLINE TM FOR THC (January 11, 1991)
  • K843534 — ORAL THC-CANNABINOIDS DIRECT RIA KIT (October 30, 1984)
  • K833911 — URINE THC CANNABINOIDS DIRECT RIA KIT (January 24, 1984)

FDA data resources