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510(k) K993491

QUICKPAC II ONE STEP OPIATES TEST by Syntron Bioresearch, Inc. — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1999
Date Received
October 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

Other clearances by Syntron Bioresearch, Inc.

  • 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)
  • K974712 — QUIKSTRIP ONE STEP BARBITURATE TEST (February 12, 1998)

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