FDA 510(k) Applications Submitted by JOHN CHEN

FDA 510(k) Number Submission Date Device Name Applicant
K920046 01/06/1992 MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K980093 01/09/1998 DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE UNIVERSAL GLOVES CORP.
K920253 01/21/1992 MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K920299 01/22/1992 MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K920345 01/27/1992 PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) MEDIX BIOTECH, INC.
K920504 02/05/1992 MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K050303 02/08/2005 5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. MESURE TECHNOLOGY CO.,LTD.
K920712 02/18/1992 MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K010829 03/20/2001 POWDER FREE ELASTIC VINYL EXAMINATION GLOVES GENERAL GLOVES CORP.
K010830 03/20/2001 POWDER FREE TEXTURED VINYL EXAMINATION GLOVES GENERAL GLOVES CORP.
K080981 04/07/2008 EAR THERMOMETER, MODELS ST66 AND ST67 MESURE TECHNOLOGY CO.,LTD.
K921700 04/08/1992 TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 MEDIX BIOTECH, INC.
K071019 04/10/2007 DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES MESURE TECHNOLOGY CO.,LTD.
K922047 05/01/1992 IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 MEDIX BIOTECH, INC.
K932482 05/24/1993 MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 MEDIX BIOTECH, INC.
K932758 06/03/1993 MEDIX BIOTECH BESTEST HCG-URINE TEST KIT MEDIX BIOTECH, INC.
K042013 07/27/2004 DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F MESURE TECHNOLOGY CO.,LTD.
K924259 08/24/1992 MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 MEDIX BIOTECH, INC.
K042627 09/27/2004 EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 MESURE TECHNOLOGY CO.,LTD.
K914696 10/18/1991 MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011 MEDIX BIOTECH, INC.
K914756 10/22/1991 ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT MEDIX BIOTECH, INC.
K925436 10/28/1992 MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT MEDIX BIOTECH, INC.
K063542 11/24/2006 WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. MESURE TECHNOLOGY CO.,LTD.
K023956 11/27/2002 THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F MESURE TECHNOLOGY CO.,LTD.
K024174 12/18/2002 NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES GENERAL GLOVES CORP.
K024338 12/27/2002 POWDER FREE VINYL EXAM GLOVES WITH ALOE COATING INSIDE GENERAL GLOVES CORP.


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