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 |