Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800 Instrument Application
FDA 510(k) K951319 · Roche Diagnostic Systems, Inc.
510(k) numberK951319
Submission
- Device name
- Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800 Instrument Application
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- March 23, 1995
- Decision date
- June 1, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| 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 |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800 Instrument Application cleared by the FDA?
Roche Abuscreen Online for Opiates 1000 Test KIT-2000 Ng/Ml Cutoff Olympus AU800 Instrument Application (K951319) received a 510(k) decision of Substantially Equivalent on June 1, 1995, 70 days after the submission was received.
What is the product code of K951319?
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.