Medical Device Manufacturer · US , Poway , CA

Alfa Scientific Designs, Inc. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1999
43
Total
43
Cleared
0
Denied

Alfa Scientific Designs, Inc. has 43 FDA 510(k) cleared toxicology devices. Based in Poway, US.

Historical record: 43 cleared submissions from 1999 to 2018.

Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.

43 devices
1–12 of 43
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
K173303 · DKZ Enzyme Immunoassay, Amphetamine · Toxicology
Feb 2018 128d
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · KHE Reagent, Occult Blood · Hematology
Feb 2018 136d
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
K152122 · DKZ Enzyme Immunoassay, Amphetamine · Toxicology
Jun 2016 330d
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
K131645 · DKZ Enzyme Immunoassay, Amphetamine · Toxicology
Oct 2013 124d
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
K100051 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2010 179d
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · KHE Reagent, Occult Blood · Hematology
Jun 2007 104d
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
K063545 · DJG Enzyme Immunoassay, Opiates · Toxicology
May 2007 164d
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
K060527 · DJG Enzyme Immunoassay, Opiates · Toxicology
Jul 2006 147d
INSTANT-VIEW TROPONIN I TEST
K042227 · MMI Immunoassay Method, Troponin Subunit · Chemistry
Nov 2004 94d
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
K024360 · LYR Helicobacter Pylori · Microbiology
Jun 2003 162d
INSTANT-VIEW TCA URINE TEST
K022693 · MLK Thin Layer Chromatography, Tricyclic Antidepressant Drugs · Toxicology
Dec 2002 118d
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · JXN Enzyme Immunoassay, Propoxyphene · Chemistry
Nov 2002 87d

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All43 Toxicology 31 Chemistry 8 Hematology 3 Microbiology 1