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510(k) K992068

STATUS STIK, ACCUSIGN STIK by Princeton BioMeditech Corp. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1999
Date Received
June 18, 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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  • 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)
  • 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)