The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Radioimmunoassay Of No Spin(tm) Cortisol.
| Device ID | K862871 |
| 510k Number | K862871 |
| Device Name: | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Contact | Anne M Kulis |
| Correspondent | Anne M Kulis CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-08-19 |