Alfa Scientific Designs, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 43
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Dru | February 23, 2018 |
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | February 15, 2018 |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Us | June 24, 2016 |
| K131645 | INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) | October 7, 2013 |
| K100051 | INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE | July 6, 2010 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | June 21, 2007 |
| K063545 | MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, | May 7, 2007 |
| K060527 | INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NB | July 25, 2006 |
| K042227 | INSTANT-VIEW TROPONIN I TEST | November 19, 2004 |
| K024360 | INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST | June 10, 2003 |
| K022693 | INSTANT-VIEW TCA URINE TEST | December 9, 2002 |
| K022915 | INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST | November 29, 2002 |
| K022501 | INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST | November 13, 2002 |
| K022829 | INSTANT-VIEW LH OVULATION PREDICTING TEST | November 5, 2002 |
| K022564 | INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST | August 30, 2002 |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | June 17, 2002 |
| K010047 | INSTANT-VIEW PHENCYCLIDINE (PCP) URINE CASSETTE TEST | May 29, 2001 |
| K010015 | INSTANT-VIEW METHADONE URINE CASSETTE TEST | May 29, 2001 |
| K003845 | MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP) | May 29, 2001 |
| K010125 | INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST | May 29, 2001 |