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510(k) K991751

STATUS CUP ACCUSIGN CUP by Princeton BioMeditech Corp. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1999
Date Received
May 24, 1999
Clearance Type
Special
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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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)
  • 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)
  • 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)
  • K831456 — TOXI-LAB CANNABINOID THC SCREEN (June 30, 1983)