Princeton BioMeditech Corp. - FDA 510(k) Cleared Devices
Recent clearances: Status™ COVID-19/Flu A&B, BioSign Flu A+B
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - Princeton BioMeditech Corp. Chemistry ✕
14 devices
Cleared
Feb 20, 2007
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
Chemistry
173d
Cleared
Jan 23, 2006
LIFESIGN DXPRESS, MODEL LSR2000
Chemistry
283d
Cleared
Oct 08, 2002
LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
Chemistry
34d
Cleared
May 23, 2002
STATUS HCG SERUM/URINE
Chemistry
101d
Cleared
May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN...
Chemistry
52d
Cleared
Jul 22, 1998
BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY...
Chemistry
91d
Cleared
Jul 06, 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
Chemistry
39d
Cleared
Jun 25, 1998
BIOSIGN HCG I - ONE STEP PREGNANCY TEST
Chemistry
64d
Cleared
Dec 24, 1997
BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST,...
Chemistry
30d
Cleared
Nov 07, 1996
CARDIAC STATUS TROPONIN I
Chemistry
65d
Cleared
Mar 01, 1995
BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST
Chemistry
35d
Cleared
Feb 22, 1995
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN
Chemistry
173d
Cleared
Feb 10, 1995
LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG
Chemistry
93d
Cleared
Oct 25, 1994
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
Chemistry
43d