The following data is part of a premarket notification filed by Hemodiagnostica, Llc with the FDA for Sdi Ca480 Clinical Chemistry System; Saturno 300 Clinical Chemistry System.
| Device ID | K061879 |
| 510k Number | K061879 |
| Device Name: | SDI CA480 CLINICAL CHEMISTRY SYSTEM; SATURNO 300 CLINICAL CHEMISTRY SYSTEM |
| Classification | Hexokinase, Glucose |
| Applicant | HEMODIAGNOSTICA, LLC 130 GARDENERS CIRCLE Johns Island, SC 29455 |
| Contact | Bruno Borganti |
| Correspondent | Bruno Borganti HEMODIAGNOSTICA, LLC 130 GARDENERS CIRCLE Johns Island, SC 29455 |
| Product Code | CFR |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-12-15 |
| Summary: | summary |