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510(k) K792282

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG by California Medical Developments, Inc. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1980
Date Received
November 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagents, Test, Tetrahydrocannabinol
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

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  • K901694 — SPEC(TM) EXTRACTION CARTRIDGE (June 1, 1990)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)