Alfa Scientific Designs, Inc.
Poway, CA, US
ALFA SCIENTIFIC DESIGNS, INC. appears in FDA device records in Poway, CA. FDA records list 43 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Alfa Scientific Designs, Inc. between 1999 and 2018. The busiest year on record is 2001, with 12. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 5 |
| 2000 | 10 |
| 2001 | 12 |
| 2002 | 6 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2010 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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) | DKZ | Substantially Equivalent | |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | KHE | Substantially Equivalent | |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | DKZ | Substantially Equivalent | |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | DKZ | Substantially Equivalent | |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) | DJG | Substantially Equivalent | |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | KHE | Substantially Equivalent | |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE | DJG | Substantially Equivalent | |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST | DJG | Substantially Equivalent | |
| K042227 | INSTANT-VIEW TROPONIN I TEST | MMI | Substantially Equivalent | |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | LYR | Substantially Equivalent | |
| K022693 | INSTANT-VIEW TCA URINE TEST | MLK | Substantially Equivalent | |
| K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | JXN | Substantially Equivalent | |
| K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | DJC | Substantially Equivalent | |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | CEP | Substantially Equivalent | |
| K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST | DKZ | Substantially Equivalent | |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | KHE | Substantially Equivalent | |
| K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | DIS | Substantially Equivalent | |
| K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | DOE | Substantially Equivalent | |
| K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | DOE | Substantially Equivalent | |
| K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | LCM | Substantially Equivalent | |
| K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST | LCM | Substantially Equivalent | |
| K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST | DJR | Substantially Equivalent | |
| K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST | DJR | Substantially Equivalent | |
| K003881 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST | JXM | Substantially Equivalent | |
| K003879 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) | JXM | Substantially Equivalent | |
| K003847 | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) | LAF | Substantially Equivalent | |
| K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) | LAF | Substantially Equivalent | |
| K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST | DIS | Substantially Equivalent | |
| K994406 | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST | DJC | Substantially Equivalent | |
| K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST | DIO | Substantially Equivalent | |
| K994395 | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST | DKZ | Substantially Equivalent | |
| K994400 | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST | DJC | Substantially Equivalent | |
| K994399 | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST | DKZ | Substantially Equivalent | |
| K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST | DIO | Substantially Equivalent | |
| K994409 | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST | DPK | Substantially Equivalent | |
| K994404 | INSTANT-VIEW MORPHINE URINE CASSETTE TEST | DPK | Substantially Equivalent | |
| K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST | LDJ | Substantially Equivalent | |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | DKE | Substantially Equivalent | |
| K984080 | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST | JHI | Substantially Equivalent | |
| K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST | JHI | Substantially Equivalent | |
| K984077 | INSTANT-VIEW PREGNANCY COMBO TEST | JHI | Substantially Equivalent | |
| K984076 | INSTANT-VIEW PREGNANCY URINE TEST | JHI | Substantially Equivalent | |
| K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2060833 | 3001452245 | ALFA SCIENTIFIC DESIGNS, INC. | 13200 GREGG ST., POWAY, CA 92064 US | 2026 | and 29 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- GTYAntigens, All Groups, Streptococcus Spp.
- DIFDrug Mixture Control Materials
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- LYRHelicobacter Pylori
- MMIImmunoassay Method, Troponin Subunit
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- DPKLiquid Chromatography, Morphine
- CEPRadioimmunoassay, Luteinizing Hormone
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- DKEReagents, Test, Tetrahydrocannabinol
- NFTTest, Amphetamine, Over The Counter
- PTHTest, Barbiturate, Over The Counter
- NFVTest, Benzodiazepine, Over The Counter
- NFWTest, Cannabinoid, Over The Counter
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- PTGTest, Methadone, Over The Counter
- NGGTest, Methamphetamine, Over The Counter
- NGITest, Morphine, Over The Counter
- NGLTest, Opiates, Over The Counter
- NGMTest, Phencyclidine (Pcp), Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- MLKThin Layer Chromatography, Tricyclic Antidepressant Drugs
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain