The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Parathyroid Hormone Radioimmunoassay Kit.
| Device ID | K850254 |
| 510k Number | K850254 |
| Device Name: | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Contact | Carole Varanelli |
| Correspondent | Carole Varanelli CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-22 |
| Decision Date | 1985-04-03 |