Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133D
FDA 510(k) K002418 · Branan Medical Corporation
510(k) numberK002418
Submission
- Device name
- Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133D
- Applicant
- Branan Medical Corporation
Irvine, CA, US - Received
- August 8, 2000
- Decision date
- November 22, 2000
- 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 |
| 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 |
|---|---|---|
| K122633 | Toxcup Drug Screen CupLDJ · Traditional | 02/07/2013SE |
| K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…JXN · Traditional | 01/30/2013SE |
| K103227 | Oratect Oral Fluid Drug Screen DevicesDIO · Traditional | 04/11/2012SE |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardDJG · Traditional | 11/21/2008SE |
| K040203 | Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen…DKZ · Traditional | 03/25/2004SE |
| K032057 | Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/ThcDIO · Special | 08/21/2003SE |
| K030113 | Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen…DJG · Traditional | 07/02/2003SE |
| K023489 | Quicktox Multiple Drug DipcardDIO · Special | 12/16/2002SE |
| K022355 | Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61DIO · Special | 07/30/2002SE |
| K013124 | Modification to Scooper Drug/Adulteration Test CupDJJ · Special | 11/07/2001SE |
Questions and answers
When was Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133D cleared by the FDA?
Branan Medical Corporation Monitect Morphine 300 Drug Screen Test, Model 133C and 133D (K002418) received a 510(k) decision of Substantially Equivalent on November 22, 2000, 106 days after the submission was received.
What is the product code of K002418?
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.