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510(k) K963654

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST by Syntron Bioresearch, Inc. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1997
Date Received
September 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Syntron Bioresearch, Inc.

  • K993491 — QUICKPAC II ONE STEP OPIATES TEST (October 29, 1999)
  • K993490 — QUICKSTRIP ONE STEP OPIATES TEST (October 29, 1999)
  • K992990 — QUICKPAC II ONE STEP COCAINE TEST (September 20, 1999)
  • K992748 — DRUGCHECK X MULTIDRUG SCREENING DEVICE (September 2, 1999)
  • K992207 — QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM (July 22, 1999)
  • K990325 — QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE (June 24, 1999)
  • K983113 — BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT (November 18, 1998)
  • K981292 — QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST (May 26, 1998)
  • K981019 — QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST (May 7, 1998)
  • K980349 — QUICKPAC II ONE STEP BARBITURATE TEST (March 3, 1998)

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