Syntron Bioresearch, Inc. - FDA 510(k) Cleared Devices
Recent clearances: QUICKSTRIP ONE STEP OPIATES TEST, QUICKPAC II ONE STEP OPIATES TEST, QUICKPAC II ONE STEP COCAINE TEST
26
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syntron Bioresearch, Inc. Chemistry ✕
12 devices
Cleared
Nov 18, 1998
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
Chemistry
75d
Cleared
Dec 02, 1996
MIDSTREAM ONESTEP PREGNANCY HOME TEST
Chemistry
98d
Cleared
Mar 19, 1996
PLATFORM ONESTEP PREGNANCY HOME TEST
Chemistry
68d
Cleared
Jul 11, 1995
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
Chemistry
99d
Cleared
Feb 08, 1995
QUIKPAC II, ONE STEP HCG COMBO KIT
Chemistry
64d
Cleared
Apr 06, 1993
BESURE PLUS/(MIDSTREAM) ONE STEP PREG HOME TEST
Chemistry
67d
Cleared
May 29, 1992
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
Chemistry
81d
Cleared
Jul 24, 1991
QUIKPAC-II ONE STEP PREGNANCY HOME TEST
Chemistry
61d
Cleared
Nov 04, 1987
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST
Chemistry
19d
Cleared
Jun 11, 1987
MICROCHECK LH OVULATION TEST
Chemistry
48d
Cleared
May 20, 1987
SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST
Chemistry
84d
Cleared
Feb 11, 1987
SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST
Chemistry
44d