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510(k) K901694

SPEC(TM) EXTRACTION CARTRIDGE by Toxi-Lab, Inc. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1990
Date Received
April 10, 1990
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

Other clearances by Toxi-Lab, Inc.

  • K932209 — TOXI*LAB LTD OPIATE SYSTEM (September 24, 1993)
  • K923337 — ON*SITE ALCOHOL (January 12, 1993)
  • K903223 — ON-SITE ALCOHOL (March 13, 1991)
  • K900626 — ALPHA URINE SAMPLE (March 6, 1990)

Other clearances for product code DKE

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  • K994405 — INSTANT-VIEW MARIJUANA URINE CASSETTE TEST (June 2, 2000)
  • K992068 — STATUS STIK, ACCUSIGN STIK (July 6, 1999)
  • K991751 — STATUS CUP ACCUSIGN CUP (June 18, 1999)
  • K991078 — ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OP (April 15, 1999)
  • K983147 — ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, (September 28, 1998)
  • K982211 — PROFILE-II MODEL 600582 (July 29, 1998)
  • K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN (July 5, 1988)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)
  • K831456 — TOXI-LAB CANNABINOID THC SCREEN (June 30, 1983)