FDA 510(k) Applications Submitted by CARL A MONGIOVI

FDA 510(k) Number Submission Date Device Name Applicant
K070009 01/03/2007 AT HOME DRUG TEST MODELS, 9308T AND 9308X PHAMATECH INC.
K070098 01/10/2007 QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC PHAMATECH INC.
K990249 01/26/1999 OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 PHAMATECH
K030447 02/11/2003 AT HOME DRUG CUP, MODEL 9150X PHAMATECH
K040575 03/04/2004 PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 PHAMATECH INC.
K991095 04/01/1999 QUICKCARD HCG COMBO TEST, MODEL #9014 PHAMATECH
K001397 05/03/2000 QUICKSCREEN PRO DRUG CUP, MODEL 9195X PHAMATECH
K041578 06/14/2004 QUICKSCREEN, MODELS 9177X AND 9178X PHAMATECH
K972577 07/10/1997 QUICK SCREEN ONE STEP AMPHETAMINE TEST PHAMATECH
K972619 07/11/1997 QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080) PHAMATECH
K972618 07/11/1997 QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070) PHAMATECH
K973570 09/19/1997 QUICK CARD HCG ONE STEP PREGNANCY TEST PHAMATECH
K013412 10/15/2001 AT HOME DRUG TEST, MODEL 9069 PHAMATECH INC.
K013410 10/15/2001 AT HOME DRUG TEST, MODEL 9064 PHAMATECH INC.
K013407 10/15/2001 AT HOME DRUG TEST, MODEL 9084 PHAMATECH INC.
K013409 10/15/2001 AT HOME DRUG TEST, MODEL 9074 PHAMATECH INC.
K013408 10/15/2001 AT HOME DRUG TEST, MODEL 9079 PHAMATECH INC.
K043051 11/04/2004 QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 PHAMATECH INC.
K103295 11/08/2010 QUICKSCREEN COCAINE 150 SCREENING TEST PHAMATECH INC.
K043167 11/16/2004 PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X PHAMATECH INC.
K000131 01/18/2000 QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 PHAMATECH
K000447 02/10/2000 QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 PHAMATECH
K980532 02/11/1998 QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 PHAMATECH
K010645 03/05/2001 AT HOME DRUG TEST, MODEL 9063 T PHAMATECH
K010655 03/05/2001 AT HOME DRUG TESTT, MODEL 9150 T PHAMATECH
K010654 03/05/2001 AT HOME DRUG TEST, MODEL 9078 T PHAMATECH
K010653 03/05/2001 AT HOME DRUG TEST, MODEL 9068 T PHAMATECH
K010650 03/05/2001 AT HOME DRUG TEST, MODEL 9073 T PHAMATECH
K010646 03/05/2001 AT HOME DRUG TEST, MODEL 9083 T PHAMATECH
K010651 03/05/2001 AT HOME DRUG TEST, MODEL 9133 T PHAMATECH
K980896 03/09/1998 QUICKCARD PRO HCG TEST, MODEL 9008 PHAMATECH
K010836 03/20/2001 AT WORK DRUG TEST, MODEL 9147T AWT PHAMATECH
K010833 03/20/2001 AT WORK DRUG TEST, MODEL 9177T AWT PHAMATECH
K131069 04/17/2013 QUICKSCREEN AMPHETINE 500 TEST PHAMATECH INC.
K021409 05/03/2002 AT HOME OVULATION TEST, MODEL 9032 PHAMATECH INC.
K991641 05/12/1999 AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 PHAMATECH
K981687 05/13/1998 QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 PHAMATECH
K991824 05/27/1999 AT HOME DRUG TEST, MODEL 9171 PHAMATECH
K982152 06/18/1998 QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 PHAMATECH
K992217 07/01/1999 AT HOME DRUG TEST, MODEL 9175 PHAMATECH
K982621 07/28/1998 QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 PHAMATECH
K992685 08/10/1999 QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C PHAMATECH
K973122 08/20/1997 QUICKSCREEN ONE STEP THC SCREENING TEST PHAMATECH
K993141 09/21/1999 AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 PHAMATECH
K993165 09/22/1999 QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 PHAMATECH
K994093 12/03/1999 AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C PHAMATECH
K974582 12/08/1997 QUICKSCREEN ONE STEP PCP SCREENING TEST PHAMATECH
K974615 12/11/1997 QUICKSTICK PRO HCG TEST PHAMATECH
K003858 12/13/2000 MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 PHAMATECH
K994219 12/15/1999 AT HOME DRUG TEST, MODEL 9073 PHAMATECH
K994220 12/15/1999 AT HOME DRUG TEST, MODEL 9078 PHAMATECH
K994233 12/16/1999 AT HOME DRUG TEST, MODEL 9068 PHAMATECH
K994234 12/16/1999 AT HOME DRUG TEST, MODEL 9083 PHAMATECH
K994236 12/16/1999 AT HOME DRUG TEST, MODEL 9133 PHAMATECH
K994237 12/16/1999 AT HOME DRUG TEST, MODEL 9063 PHAMATECH
K043599 12/29/2004 MOMENTS MENOPAUSE CHECK, MODEL 9113 PHAMATECH INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact