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510(k) K875182

MODIFIED LABELING FOR TOXI-LAB THC SCREEN by Marion Laboratories, Inc. — Product Code DKE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1988
Date Received
December 17, 1987
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 Marion Laboratories, Inc.

  • K883391 — POLYMER ADHESIVE BANDAGE (March 23, 1989)
  • K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM (May 27, 1988)
  • K874554 — ENVICLUSIVE (TM) (March 11, 1988)
  • K874552 — ENVISAN PAD (January 22, 1988)
  • K874551 — ENVINET(TM) (January 22, 1988)
  • K874553 — ENVISAN PASTE (December 18, 1987)
  • K870864 — CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (April 14, 1987)
  • K863485 — MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST (September 17, 1986)
  • K862123 — BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE (June 16, 1986)
  • K853073 — CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. (August 1, 1985)

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)
  • K901694 — SPEC(TM) EXTRACTION CARTRIDGE (June 1, 1990)
  • K841831 — CANNU-SKREEN-PRELIMINARY (July 6, 1984)
  • K831456 — TOXI-LAB CANNABINOID THC SCREEN (June 30, 1983)