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 |