Alfa Scientific Designs, Inc. is one of 25914 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Alfa Scientific Designs, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Instant-View® hCG Combo II Cassette Test, INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use), Instant-view-PLUS immunochemical Fecal Occult Blood Test
44
Total
44
Cleared
0
Denied
Alfa Scientific Designs, Inc. has 44 FDA 510(k) cleared toxicology devices. Based in Poway, US.
Latest FDA clearance: Sep 2026. Active since 1999.
Browse the complete list of FDA 510(k) cleared toxicology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by LSI International, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Alfa Scientific Designs, Inc.
44 devices
Cleared
Sep 22, 2026
Instant-View® hCG Combo II Cassette Test
Chemistry
77d
Cleared
Feb 23, 2018
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use),...
Toxicology
128d
Cleared
Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
Hematology
136d
Cleared
Jun 24, 2016
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug...
Toxicology
330d
Cleared
Oct 07, 2013
INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
Toxicology
124d
Cleared
Jul 06, 2010
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT...
Toxicology
179d
Cleared
Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
Hematology
104d
Cleared
May 07, 2007
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE...
Toxicology
164d
Cleared
Jul 25, 2006
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
Toxicology
147d
Cleared
Nov 19, 2004
INSTANT-VIEW TROPONIN I TEST
Chemistry
94d
Cleared
Jun 10, 2003
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
Microbiology
162d
Cleared
Dec 09, 2002
INSTANT-VIEW TCA URINE TEST
Toxicology
118d
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