The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Cortisol Kit.
| Device ID | K830148 |
| 510k Number | K830148 |
| Device Name: | CORTISOL KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | CAMBRIDGE MEDICAL TECHNOLOGY MA |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-17 |
| Decision Date | 1983-02-09 |