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

Cleared Jun 18, 1999

STATUS CUP ACCUSIGN CUP

K991751 · DKE

Toxicology · 25d

Cleared May 28, 1999

MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN...

K991299 · JHT

Chemistry · 52d

Cleared Apr 15, 1999

ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR

K991018 · DIS

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3,...

K991076 · DIS

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8,...

K991078 · DKE

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO

K991079 · JXM

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN MTD, BIOSIGN MTD

K991080 · DJR

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA...

K991082 · DIS

Toxicology · 20d

Cleared Apr 15, 1999

ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD

K991084 · DIS

Toxicology · 20d

Cleared Mar 26, 1999

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN...

K990786 · LAG

Toxicology · 16d

Cleared Dec 18, 1998

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN...

K983501 · LAG

Toxicology · 73d

Cleared Nov 25, 1998

BIOSTREP A-DIRECT STREP A ANTIGEN TEST

K983386 · GTY

Microbiology · 60d

Cleared Sep 28, 1998

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN...

K983147 · DKE

Toxicology · 20d

Cleared Sep 22, 1998

BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST

K980798 · LYR

Microbiology · 204d

Cleared Aug 25, 1998

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

K981801 · LFH

Toxicology · 96d

Cleared Jul 22, 1998

BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY...

K981444 · JHI

Chemistry · 91d

Cleared Jul 06, 1998

CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

K981882 · MMI

Chemistry · 39d

Cleared Jun 25, 1998

BIOSIGN HCG I - ONE STEP PREGNANCY TEST

K981443 · JHI

Chemistry · 64d

Cleared Jun 12, 1998

ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP

K981771 · DJG

Toxicology · 24d

Cleared Mar 13, 1998

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA

K980249 · LFG

Toxicology · 49d

Cleared Dec 24, 1997

BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST,...

K974425 · DHA

Chemistry · 30d

Cleared Dec 11, 1997

ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN...

K974181 · JXM

Toxicology · 35d

Cleared Jul 07, 1997

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

K971349 · GTY

Microbiology · 88d

Cleared Feb 04, 1997

BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB

K961024 · KTN

Immunology · 327d

Cleared Nov 29, 1996

OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST

K963693 · CEP

Toxicology · 74d