The following data is part of a premarket notification filed by Immunodiagnostic Systems Ltd. with the FDA for Octeia Igf-1 Kit.
| Device ID | K950510 |
| 510k Number | K950510 |
| Device Name: | OCTEIA IGF-1 KIT |
| Classification | Radioimmunoassay, Human Growth Hormone |
| Applicant | IMMUNODIAGNOSTIC SYSTEMS LTD. BOLDEN BUSINESS PARK BOLDON Tyne And Wear, GB Ne35 9pd |
| Contact | Anita Groundwater |
| Correspondent | Anita Groundwater IMMUNODIAGNOSTIC SYSTEMS LTD. BOLDEN BUSINESS PARK BOLDON Tyne And Wear, GB Ne35 9pd |
| Product Code | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-04-05 |