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Alfa Scientific Designs, Inc.

FDA 510(k) & PMA Approved Devices — 44 products

Total Devices44
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262299 Instant-View® hCG Combo II Cassette TestJHI2026-09-22 View
510(k) K173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)DKZ2018-02-23 View
510(k) K173212 Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE2018-02-15 View
510(k) K152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)DKZ2016-06-24 View
510(k) K131645 INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)DKZ2013-10-07 View
510(k) K100051 INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)DJG2010-07-06 View
510(k) K070660 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TESTKHE2007-06-21 View
510(k) K063545 MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINEDJG2007-05-07 View
510(k) K060527 INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TESTDJG2006-07-25 View
510(k) K042227 INSTANT-VIEW TROPONIN I TESTMMI2004-11-19 View
510(k) K024360 INSTANT-VIEW H. PYLORI ONE STEP RAPID TESTLYR2003-06-10 View
510(k) K022693 INSTANT-VIEW TCA URINE TESTMLK2002-12-09 View
510(k) K022915 INSTANT-VIEW PROPOXYPHENE (PPX) URINE TESTJXN2002-11-29 View
510(k) K022501 INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TESTDJC2002-11-13 View
510(k) K022829 INSTANT-VIEW LH OVULATION PREDICTING TESTCEP2002-11-05 View
510(k) K022564 INSTANT-VIEW MULTI-DRUG SCREEN URINE TESTDKZ2002-08-30 View
510(k) K021423 INSTANT-VIEW FECAL OCCULT BLOOD RAPID TESTKHE2002-06-17 View
510(k) K010014 INSTANT-VIEW METHADONE URINE DIP STRIP TESTDJR2001-05-29 View
510(k) K003647 INSTANT-VIEW BARBITURATE URINE CASSETTE TESTDIS2001-05-29 View
510(k) K003845 MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)LAF2001-05-29 View
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