FDA 510(k) Applications Submitted by JEMO KANG, PH.D.

FDA 510(k) Number Submission Date Device Name Applicant
K980249 01/23/1998 ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA PRINCETON BIOMEDITECH CORP.
K020439 02/11/2002 STATUS HCG SERUM/URINE PRINCETON BIOMEDITECH CORP.
K990786 03/10/1999 ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ PRINCETON BIOMEDITECH CORP.
K961010 03/13/1996 ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD PRINCETON BIOMEDITECH CORP.
K040708 03/18/2004 STATUS FIRST STREP A PRINCETON BIOMEDITECH CORP.
K991080 03/26/1999 ACCUSIGN MTD, BIOSIGN MTD PRINCETON BIOMEDITECH CORP.
K991079 03/26/1999 ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO PRINCETON BIOMEDITECH CORP.
K991078 03/26/1999 ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 PRINCETON BIOMEDITECH CORP.
K991082 03/26/1999 ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO PRINCETON BIOMEDITECH CORP.
K991076 03/26/1999 ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP PRINCETON BIOMEDITECH CORP.
K991018 03/26/1999 ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR PRINCETON BIOMEDITECH CORP.
K991084 03/26/1999 ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD PRINCETON BIOMEDITECH CORP.
K961249 04/01/1996 ACCUSIGN MET/BIOSIGN MET PRINCETON BIOMEDITECH CORP.
K961266 04/02/1996 ACCUSIGN, BIOSIGN PCP PRINCETON BIOMEDITECH CORP.
K991299 04/06/1999 MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI PRINCETON BIOMEDITECH CORP.
K961325 04/08/1996 ACCUSIGN DOA 3/DOA 3 (BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA 3/BZO/BAR/PCP, BIOSIGN BZO/BAR/PCP PRINCETON BIOMEDITECH CORP.
K971349 04/10/1997 BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST PRINCETON BIOMEDITECH CORP.
K001225 04/17/2000 ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. PRINCETON BIOMEDITECH CORP.
K981444 04/22/1998 BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP PRINCETON BIOMEDITECH CORP.
K981443 04/22/1998 BIOSIGN HCG I - ONE STEP PREGNANCY TEST PRINCETON BIOMEDITECH CORP.
K981771 05/19/1998 ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP PRINCETON BIOMEDITECH CORP.
K981801 05/21/1998 ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA PRINCETON BIOMEDITECH CORP.
K991751 05/24/1999 STATUS CUP ACCUSIGN CUP PRINCETON BIOMEDITECH CORP.
K981882 05/28/1998 CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST PRINCETON BIOMEDITECH CORP.
K992068 06/18/1999 STATUS STIK, ACCUSIGN STIK PRINCETON BIOMEDITECH CORP.
K992422 07/21/1999 ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 PRINCETON BIOMEDITECH CORP.
K963513 09/03/1996 CARDIAC STATUS TROPONIN I PRINCETON BIOMEDITECH CORP.
K022946 09/04/2002 LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST PRINCETON BIOMEDITECH CORP.
K983147 09/08/1998 ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P PRINCETON BIOMEDITECH CORP.
K983386 09/26/1998 BIOSTREP A-DIRECT STREP A ANTIGEN TEST PRINCETON BIOMEDITECH CORP.
K983501 10/06/1998 ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ PRINCETON BIOMEDITECH CORP.
K974181 11/06/1997 ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B PRINCETON BIOMEDITECH CORP.
K023837 11/18/2002 LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK MET & MDMA, ACCUSTIK MET & MDMA PRINCETON BIOMEDITECH CORP.
K974425 11/24/1997 BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST PRINCETON BIOMEDITECH CORP.
K014066 12/10/2001 LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC PRINCETON BIOMEDITECH CORP.
K014069 12/10/2001 LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC PRINCETON BIOMEDITECH CORP.
K014067 12/10/2001 LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC PRINCETON BIOMEDITECH CORP.
K014193 12/21/2001 LIFESIGN DOA 4 (THC/OPI/COC/MET) PRINCETON BIOMEDITECH CORP.
K014192 12/21/2001 LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET PRINCETON BIOMEDITECH CORP.
K980798 03/02/1998 BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST PRINCETON BIOMEDITECH CORP.
K100817 03/19/2010 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST PRINCETON BIOMEDITECH CORP.
K962353 06/18/1996 ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP) PRINCETON BIOMEDITECH CORP.
K962672 07/09/1996 ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY PRINCETON BIOMEDITECH CORP.
K962669 07/09/1996 ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY PRINCETON BIOMEDITECH CORP.
K962673 07/09/1996 ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY PRINCETON BIOMEDITECH CORP.
K963693 09/16/1996 OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST PRINCETON BIOMEDITECH CORP.


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