FDA 510(k) Applications Submitted by ALFA SCIENTIFIC DESIGNS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K063545 11/24/2006 MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE ALFA SCIENTIFIC DESIGNS, INC.
K070660 03/09/2007 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST ALFA SCIENTIFIC DESIGNS, INC.
K152122 07/30/2015 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) ALFA SCIENTIFIC DESIGNS, INC.
K003879 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC.
K010014 01/02/2001 INSTANT-VIEW METHADONE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K010015 01/02/2001 INSTANT-VIEW METHADONE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K010045 01/05/2001 INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K010047 01/05/2001 INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K010080 01/10/2001 INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K010079 01/10/2001 INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K060527 02/28/2006 INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K021423 05/03/2002 INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST ALFA SCIENTIFIC DESIGNS, INC.
K131645 06/05/2013 INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) ALFA SCIENTIFIC DESIGNS, INC.
K022501 07/29/2002 INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K022564 08/02/2002 INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K022693 08/13/2002 INSTANT-VIEW TCA URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K042227 08/17/2004 INSTANT-VIEW TROPONIN I TEST ALFA SCIENTIFIC DESIGNS, INC.
K022829 08/26/2002 INSTANT-VIEW LH OVULATION PREDICTING TEST ALFA SCIENTIFIC DESIGNS, INC.
K022915 09/03/2002 INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K984075 11/16/1998 INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST ALFA SCIENTIFIC DESIGNS, INC.
K984076 11/16/1998 INSTANT-VIEW PREGNANCY URINE TEST ALFA SCIENTIFIC DESIGNS, INC.
K984077 11/16/1998 INSTANT-VIEW PREGNANCY COMBO TEST ALFA SCIENTIFIC DESIGNS, INC.
K984079 11/16/1998 INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K984080 11/16/1998 INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K003647 11/27/2000 INSTANT-VIEW BARBITURATE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K010125 11/27/2000 INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K003845 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) ALFA SCIENTIFIC DESIGNS, INC.
K003847 12/12/2000 MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) ALFA SCIENTIFIC DESIGNS, INC.
K003881 12/15/2000 INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994395 12/28/1999 INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994398 12/28/1999 INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994399 12/28/1999 INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K994400 12/28/1999 INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994403 12/28/1999 INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K994404 12/28/1999 INSTANT-VIEW MORPHINE URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994405 12/28/1999 INSTANT-VIEW MARIJUANA URINE CASSETTE TEST ALFA SCIENTIFIC DESIGNS, INC.
K994406 12/28/1999 INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K994409 12/28/1999 INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K994410 12/28/1999 INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST ALFA SCIENTIFIC DESIGNS, INC.
K024360 12/30/2002 INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST ALFA SCIENTIFIC DESIGNS, INC.
K100051 01/08/2010 INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) ALFA SCIENTIFIC DESIGNS, INC.
K173212 10/02/2017 Instant-view-PLUS immunochemical Fecal Occult Blood Test Alfa Scientific Designs, Inc.


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