Abuscreen Radioimmunoassay for Morphine
FDA 510(k) K830460 · Hoffmann-La Roche, Inc.
510(k) numberK830460
Submission
- Device name
- Abuscreen Radioimmunoassay for Morphine
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- February 15, 1983
- Decision date
- March 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K010079 | Instant-View Morphine (2000) Urine Dip Strip 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 |
More from Roche Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
| K823579 | Cobas Reagent for Total ProteinCEK · Traditional | 01/07/1983SE |
Questions and answers
When was Abuscreen Radioimmunoassay for Morphine cleared by the FDA?
Abuscreen Radioimmunoassay for Morphine (K830460) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 37 days after the submission was received.
What is the product code of K830460?
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.