Home / 510(k) Clearances / K983147

510(k) K983147

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P by Princeton BioMeditech Corp. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1998
Date Received
September 8, 1998
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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Other clearances for product code DKE

  • K003687 — VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT (December 22, 2000)
  • 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)
  • 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)