The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii Theophylline Radioimmunoassay.
| Device ID | K833789 |
| 510k Number | K833789 |
| Device Name: | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Theophylline |
| Applicant | MEDICAL & SCIENTIFIC DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCA |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-31 |
| Decision Date | 1984-01-24 |