The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Ria-gnost Insulin.
Device ID | K890837 |
510k Number | K890837 |
Device Name: | RIA-GNOST INSULIN |
Classification | Radioimmunoassay, Immunoreactive Insulin |
Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
Contact | M Krawczyk |
Correspondent | M Krawczyk CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica, MA 01865 |
Product Code | CFP |
CFR Regulation Number | 862.1405 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-21 |
Decision Date | 1989-04-26 |