Instant-View Morphine (2000) Urine Dip Strip Test
FDA 510(k) K010079 · Alfa Scientific Designs, Inc.
510(k) numberK010079
Submission
- Device name
- Instant-View Morphine (2000) Urine Dip Strip Test
- Applicant
- Alfa Scientific Designs, Inc.
Poway, CA, US - Received
- January 10, 2001
- Decision date
- May 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DOE – Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3640
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010080 | Instant-View Morphine (2000) Urine Cassette TestDOE · Traditional | Alfa Scientific Designs, Inc. | 05/29/2001SE |
| K011011 | Livesure Morphine Screen TestDOE · Traditional | Pan Probe Biotech, Inc. | 04/13/2001SE |
| K002418 | Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133DDOE · Traditional | Branan Medical Corporation | 11/22/2000SE |
| K951319 | Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800…DOE · Traditional | Roche Diagnostic Systems, Inc. | 06/01/1995SE |
| K935055 | Roche Abuscreen Radioimmunoassay for Morphine (High Cut-Off)DOE · Traditional | Roche Diagnostic Systems, Inc. | 08/09/1994SE |
| K933572 | Urine Heroin/Morphine Direct Ria Kit (I-125)DOE · Traditional | Immunalysis Corporation | 04/06/1994SE |
| K881102 | Micromedic Morphine Ria KitDOE · Traditional | Icn Micromedic Systems | 06/24/1988SE |
| K863913 | The DPC Coat-A-Count Serum Morphine Ria KitDOE · Traditional | Diagnostic Products Corp. | 03/19/1987SE |
| K864168 | Morphine Roche (R) Eia TestDOE · Traditional | Roche Diagnostic Systems, Inc. | 03/16/1987SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | Hoffmann-La Roche, Inc. | 03/24/1983SE |
More from Hoffmann-La Roche, 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 (2000) Urine Dip Strip Test cleared by the FDA?
Instant-View Morphine (2000) Urine Dip Strip Test (K010079) received a 510(k) decision of Substantially Equivalent on May 29, 2001, 139 days after the submission was received.
What is the product code of K010079?
The FDA product code is DOE – Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3640.