The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Serum Iron Diagnostic Test Kits.
| Device ID | K830104 |
| 510k Number | K830104 |
| Device Name: | SERUM IRON DIAGNOSTIC TEST KITS |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-01-28 |