The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii Ferritin Radioimmunoassay Kit.
| Device ID | K862960 |
| 510k Number | K862960 |
| Device Name: | PHASE II FERRITIN RADIOIMMUNOASSAY KIT |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Contact | Thomas P Monkus |
| Correspondent | Thomas P Monkus MEDICAL & SCIENTIFIC DESIGNS, INC. 273 WEYMOUTH ST. Rockland, MA 02370 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-05 |
| Decision Date | 1986-08-27 |