Medical Device Manufacturer · US , Monmouth Junction , NJ

Princeton BioMeditech Corp. - FDA 510(k) Cleared Devices

72 submissions · 72 cleared · Since 1994
72
Total
72
Cleared
0
Denied
43 devices
26-43 of 43
Cleared Dec 11, 1997
ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN...
K974181 · JXM
Toxicology · 35d
Cleared Nov 29, 1996
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
K963693 · CEP
Toxicology · 74d
Cleared Aug 30, 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · JXM
Toxicology · 52d
Cleared Aug 19, 1996
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
K962353 · DIO
Toxicology · 62d
Cleared Aug 15, 1996
ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
K962669 · DIS
Toxicology · 37d
Cleared Aug 15, 1996
ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
K962673 · DJR
Toxicology · 37d
Cleared Jun 28, 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN...
K961010 · DIS
Toxicology · 107d
Cleared Jun 12, 1996
ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP,...
K961325 · JXM
Toxicology · 65d
Cleared May 31, 1996
ACCUSIGN, BIOSIGN PCP
K961266 · LCM
Toxicology · 59d
Cleared Apr 25, 1996
ACCUSIGN MET/BIOSIGN MET
K961249 · LAF
Toxicology · 24d
Cleared Nov 03, 1995
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
K954571 · DIO
Toxicology · 32d
Cleared Oct 26, 1995
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4,...
K945549 · DIO
Toxicology · 346d
Cleared Oct 26, 1995
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
K952361 · DIO
Toxicology · 171d
Cleared Apr 13, 1995
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
K945610 · DKZ
Toxicology · 149d
Cleared Feb 22, 1995
ABUSIGN DOA4
K943439 · DKZ
Toxicology · 219d
Cleared Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550 · LDJ
Toxicology · 100d
Cleared Feb 22, 1995
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC
K945609 · DIO
Toxicology · 99d
Cleared Feb 10, 1995
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
K945608 · DJG
Toxicology · 87d
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