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510(k) K821965

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1982
Date Received
July 2, 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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Other clearances for product code LAT

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  • 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)