Home / 510(k) Clearances / K990325

510(k) K990325

QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE by Syntron Bioresearch, Inc. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1999
Date Received
February 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
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)
  • 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)
  • K974712 — QUIKSTRIP ONE STEP BARBITURATE TEST (February 12, 1998)

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