Instant-View Morphine Urine Cassette Test
FDA 510(k) K994404 · Alfa Scientific Designs, Inc.
510(k) numberK994404
Submission
- Device name
- Instant-View Morphine Urine Cassette Test
- Applicant
- Alfa Scientific Designs, Inc.
San Diego, CA, US - Received
- December 28, 1999
- Decision date
- July 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPK – Liquid Chromatography, Morphine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3640
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K994409 | Instant-View Opiates/Morphine Urine Dip Strip TestDPK · Traditional | Alfa Scientific Designs, Inc. | 07/10/2000SE |
More from Alfa Scientific Designs, Inc.
| 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 |
Questions and answers
When was Instant-View Morphine Urine Cassette Test cleared by the FDA?
Instant-View Morphine Urine Cassette Test (K994404) received a 510(k) decision of Substantially Equivalent on July 5, 2000, 190 days after the submission was received.
What is the product code of K994404?
The FDA product code is DPK – Liquid Chromatography, Morphine, a Class II (moderate risk) device regulated under 21 CFR 862.3640.