The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for The Dpc Coat-a-count Serum Morphine Ria Kit.
| Device ID | K863913 |
| 510k Number | K863913 |
| Device Name: | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT |
| Classification | Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Sidney A Aroesty |
| Correspondent | Sidney A Aroesty DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DOE |
| CFR Regulation Number | 862.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-08 |
| Decision Date | 1987-03-19 |