FDA 510(k) Applications Submitted by SYNTRON BIORESEARCH, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K960117 01/11/1996 PLATFORM ONESTEP PREGNANCY HOME TEST SYNTRON BIORESEARCH, INC.
K963341 08/26/1996 MIDSTREAM ONESTEP PREGNANCY HOME TEST SYNTRON BIORESEARCH, INC.
K983113 09/04/1998 BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT SYNTRON BIORESEARCH, INC.
K980349 01/28/1998 QUICKPAC II ONE STEP BARBITURATE TEST SYNTRON BIORESEARCH, INC.
K990325 02/02/1999 QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE SYNTRON BIORESEARCH, INC.
K981019 03/18/1998 QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST SYNTRON BIORESEARCH, INC.
K981292 04/09/1998 QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST SYNTRON BIORESEARCH, INC.
K992207 06/30/1999 QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM SYNTRON BIORESEARCH, INC.
K992748 08/16/1999 DRUGCHECK X MULTIDRUG SCREENING DEVICE SYNTRON BIORESEARCH, INC.
K992990 09/07/1999 QUICKPAC II ONE STEP COCAINE TEST SYNTRON BIORESEARCH, INC.
K963654 09/12/1996 QUIKSTRIP ONESTEP MARIJUANA (THC) TEST SYNTRON BIORESEARCH, INC.
K993490 10/15/1999 QUICKSTRIP ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC.
K993491 10/15/1999 QUICKPAC II ONE STEP OPIATES TEST SYNTRON BIORESEARCH, INC.
K974712 12/17/1997 QUIKSTRIP ONE STEP BARBITURATE TEST SYNTRON BIORESEARCH, INC.


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