Company · US
Alfa Scientific Designs, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 |
| DJC | Thin Layer Chromatography, Methamphetamine | 3 |
| DJG | Enzyme Immunoassay, Opiates | 3 |
| KHE | Reagent, Occult Blood | 3 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 |
| DOE | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. | 2 |
| DPK | Liquid Chromatography, Morphine | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 |
| LAF | Gas Chromatography, Methamphetamine | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
| LYR | Helicobacter Pylori | 1 |
| MLK | Thin Layer Chromatography, Tricyclic Antidepressant Drugs | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 22, 2026 | K262299 | Instant-View® hCG Combo II Cassette Test Alfa Scientific Designs, Inc. | JHI |
| Feb 23, 2018 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simpl Alfa Scientific Designs, Inc. | DKZ |
| Feb 15, 2018 | K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test Alfa Scientific Designs, Inc. | KHE |
| Jun 24, 2016 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) Alfa Scientific Designs, Inc. | DKZ |
| Oct 7, 2013 | K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) Alfa Scientific Designs, Inc. | DKZ |
| Jul 6, 2010 | K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) Alfa Scientific Designs, Inc. | DJG |
| Jun 21, 2007 | K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST Alfa Scientific Designs, Inc. | KHE |
| May 7, 2007 | K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE Alfa Scientific Designs, Inc. | DJG |
| Jul 25, 2006 | K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST Alfa Scientific Designs, Inc. | DJG |
| Nov 19, 2004 | K042227 | INSTANT-VIEW TROPONIN I TEST Alfa Scientific Designs, Inc. | MMI |
| Jun 10, 2003 | K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST Alfa Scientific Designs, Inc. | LYR |
| Dec 9, 2002 | K022693 | INSTANT-VIEW TCA URINE TEST Alfa Scientific Designs, Inc. | MLK |
| Nov 29, 2002 | K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST Alfa Scientific Designs, Inc. | JXN |
| Nov 13, 2002 | K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST Alfa Scientific Designs, Inc. | DJC |
| Nov 5, 2002 | K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST Alfa Scientific Designs, Inc. | CEP |
| Aug 30, 2002 | K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST Alfa Scientific Designs, Inc. | DKZ |
| Jun 17, 2002 | K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST Alfa Scientific Designs, Inc. | KHE |
| May 29, 2001 | K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DIS |
| May 29, 2001 | K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DOE |
| May 29, 2001 | K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DOE |
| May 29, 2001 | K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | LCM |
| May 29, 2001 | K010045 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | LCM |
| May 29, 2001 | K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DJR |
| May 29, 2001 | K010014 | INSTANT-VIEW METHADONE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DJR |
| May 29, 2001 | K003881 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | JXM |
| May 29, 2001 | K003879 | INSTANT-VIEW BENZODIAZEPINE (BZD) URINE TEST (DIP STRIP) Alfa Scientific Designs, Inc. | JXM |
| May 29, 2001 | K003847 | MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) Alfa Scientific Designs, Inc. | LAF |
| May 29, 2001 | K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) Alfa Scientific Designs, Inc. | LAF |
| May 29, 2001 | K003647 | INSTANT-VIEW BARBITURATE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DIS |
| Aug 14, 2000 | K994406 | INSTANT-VIEW METHAMPHETAMINE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DJC |
| Aug 14, 2000 | K994403 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DIO |
| Aug 7, 2000 | K994395 | INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DKZ |
| Aug 4, 2000 | K994400 | INSTANT-VIEW METHAMPHETAMINE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DJC |
| Aug 4, 2000 | K994399 | INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DKZ |
| Jul 27, 2000 | K994398 | INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DIO |
| Jul 10, 2000 | K994409 | INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | DPK |
| Jul 5, 2000 | K994404 | INSTANT-VIEW MORPHINE URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DPK |
| Jun 21, 2000 | K994410 | INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST Alfa Scientific Designs, Inc. | LDJ |
| Jun 2, 2000 | K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST Alfa Scientific Designs, Inc. | DKE |
| Feb 16, 1999 | K984080 | INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST Alfa Scientific Designs, Inc. | JHI |
| Feb 16, 1999 | K984079 | INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST Alfa Scientific Designs, Inc. | JHI |
| Feb 16, 1999 | K984077 | INSTANT-VIEW PREGNANCY COMBO TEST Alfa Scientific Designs, Inc. | JHI |
| Feb 16, 1999 | K984076 | INSTANT-VIEW PREGNANCY URINE TEST Alfa Scientific Designs, Inc. | JHI |
| Feb 16, 1999 | K984075 | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST Alfa Scientific Designs, Inc. | LCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||