The DPC Coat-A-Count Serum Morphine Ria Kit
FDA 510(k) K863913 · Diagnostic Products Corp.
510(k) numberK863913
Submission
- Device name
- The DPC Coat-A-Count Serum Morphine Ria Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- October 8, 1986
- Decision date
- March 19, 1987
- 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 |
| 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 |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was The DPC Coat-A-Count Serum Morphine Ria Kit cleared by the FDA?
The DPC Coat-A-Count Serum Morphine Ria Kit (K863913) received a 510(k) decision of Substantially Equivalent on March 19, 1987, 162 days after the submission was received.
What is the product code of K863913?
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.