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

Cleared Nov 07, 1996

CARDIAC STATUS TROPONIN I

K963513 · MMI

Chemistry · 65d

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 Aug 14, 1995

CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN

K952360 · DDR

Immunology · 103d

Cleared Apr 13, 1995

ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP

K945610 · DKZ

Toxicology · 149d

Cleared Mar 01, 1995

BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST

K950307 · DHA

Chemistry · 35d

Cleared Feb 22, 1995

ABUSIGN DOA4

K943439 · DKZ

Toxicology · 219d

Cleared Feb 22, 1995

LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN

K944325 · JHW

Chemistry · 173d

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

LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG

K945514 · LCX

Chemistry · 93d

Cleared Feb 10, 1995

ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI

K945608 · DJG

Toxicology · 87d

Cleared Oct 25, 1994

BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE

K944426 · JHI

Chemistry · 43d