The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic Monoclonal Antibody Tsh(mab Tsh)radioimmunoa.
| Device ID | K851329 |
| 510k Number | K851329 |
| Device Name: | MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-06-13 |