Alfa Scientific Designs, Inc.
Medical device manufacturer in Powat, CA.
43510(k) clearances
0PMA approvals
0recalls
Device types
- DKZ Enzyme Immunoassay, Amphetamine 6
- JHI Visual, Pregnancy Hcg, Prescription Use 4
- DJG Enzyme Immunoassay, Opiates 3
- KHE Reagent, Occult Blood 3
- DJC Thin Layer Chromatography, Methamphetamine 3
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 2
- DPK Liquid Chromatography, Morphine 2
- DIS Enzyme Immunoassay, Barbiturate 2
- LAF Gas Chromatography, Methamphetamine 2
- JXM Enzyme Immunoassay, Benzodiazepine 2
- DJR Enzyme Immunoassay, Methadone 2
- LCM Enzyme Immunoassay, Phencyclidine 2
- DOE Radioimmunoassay, Morphine (125-I), Goat… 2
- LDJ Enzyme Immunoassay, Cannabinoids 1
- DKE Reagents, Test, Tetrahydrocannabinol 1
- CEP Radioimmunoassay, Luteinizing Hormone 1
- JXN Enzyme Immunoassay, Propoxyphene 1
- MLK Thin Layer Chromatography, Tricyclic… 1
- LYR Helicobacter Pylori 1
- MMI Immunoassay Method, Troponin Subunit 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | 02/23/2018SE |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | 02/15/2018SE |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test…DKZ · Traditional | 06/24/2016SE |
| K131645 | Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)DKZ · Abbreviated | 10/07/2013SE |
| K100051 | Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of…DJG · Abbreviated | 07/06/2010SE |
| K070660 | Instant-View Fecal Occult Blood (Fob) Rapid TestKHE · Traditional | 06/21/2007SE |
| K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test(Cassette…DJG · Abbreviated | 05/07/2007SE |
| K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test…DJG · Abbreviated | 07/25/2006SE |
| K042227 | Instant-View Troponin I TestMMI · Traditional | 11/19/2004SE |
| K024360 | Instant-View H. Pylori One Step Rapid TestLYR · Traditional | 06/10/2003SE |
| K022693 | Instant-View Tca Urine TestMLK · Abbreviated | 12/09/2002SE |
| K022915 | Instant-View Propoxyphene (PPX) Urine TestJXN · Traditional | 11/29/2002SE |
| K022501 | Instant-View Mdma (Ecstasy, XTC) Urine TestDJC · Abbreviated | 11/13/2002SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | 11/05/2002SE |
| K022564 | Instant-View Multi-Drug Screen Urine TestDKZ · Special | 08/30/2002SE |
| K021423 | Instant-View Fecal Occult Blood Rapid TestKHE · Abbreviated | 06/17/2002SE |
| K010125 | Instant-View Barbituate Urine Dip Strip TestDIS · Traditional | 05/29/2001SE |
| K010080 | Instant-View Morphine (2000) Urine Cassette TestDOE · Traditional | 05/29/2001SE |
| K010079 | Instant-View Morphine (2000) Urine Dip Strip TestDOE · Traditional | 05/29/2001SE |
| K010047 | Instant-View Phencyclidine (PCP) Urine Cassette TestLCM · Traditional | 05/29/2001SE |
| K010045 | Instant-View Phencyclidine (PCP) Urine Dip Strip TestLCM · Traditional | 05/29/2001SE |
| K010015 | Instant-View Methadone Urine Cassette TestDJR · Traditional | 05/29/2001SE |
| K010014 | Instant-View Methadone Urine Dip Strip TestDJR · Traditional | 05/29/2001SE |
| K003881 | Instant-View Benzodiazepine (BZD) Urine Cassette TestJXM · Traditional | 05/29/2001SE |
| K003879 | Instant-View Benzodiazepine (BZD) Urine Test (Dip Strip)JXM · Traditional | 05/29/2001SE |
| K003847 | Modification to Instant-View Methamphetyamine (METH1000) Urine Test (Cassette)LAF · Traditional | 05/29/2001SE |
| K003845 | Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip)LAF · Traditional | 05/29/2001SE |
| K003647 | Instant-View Barbiturate Urine Cassette TestDIS · Traditional | 05/29/2001SE |
| K994406 | Instant-View Methamphetamine Urine Dip Strip TestDJC · Traditional | 08/14/2000SE |
| K994403 | Instant-View Cocaine (Benzylecgonine) Urine Dip Strip TestDIO · Traditional | 08/14/2000SE |
| K994395 | Instant-View Amphetamine Urine Cassette TestDKZ · Traditional | 08/07/2000SE |
| K994400 | Instant-View Methamphetamine Urine Cassette TestDJC · Traditional | 08/04/2000SE |
| K994399 | Instant-View Amphetamine Urine Dip Strip TestDKZ · Traditional | 08/04/2000SE |
| K994398 | Instant-View Cocaine (Benzylecgonine) Urine Cassette TestDIO · Traditional | 07/27/2000SE |
| K994409 | Instant-View Opiates/Morphine Urine Dip Strip TestDPK · Traditional | 07/10/2000SE |
| K994404 | Instant-View Morphine Urine Cassette TestDPK · Traditional | 07/05/2000SE |
| K994410 | Instant-View Marijuana (THC) Urine Dip Strip TestLDJ · Traditional | 06/21/2000SE |
| K994405 | Instant-View Marijuana Urine Cassette TestDKE · Traditional | 06/02/2000SE |
| K984080 | Instant-View Pregnancy Combo Dip-Strip TestJHI · Traditional | 02/16/1999SE |
| K984079 | Instant-View Pregnancy Urine Dip-Strip TestJHI · Traditional | 02/16/1999SE |
| K984077 | Instant-View Pregnancy Combo TestJHI · Traditional | 02/16/1999SE |
| K984076 | Instant-View Pregnancy Urine TestJHI · Traditional | 02/16/1999SE |
| K984075 | Instant-View Pregnancy Urine Mid-Stream TestLCX · Traditional | 02/16/1999SE |