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 |