The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Diagnostic Kit Free T3 And Free T4.
| Device ID | K870268 |
| 510k Number | K870268 |
| Device Name: | DIAGNOSTIC KIT FREE T3 AND FREE T4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | King, Ph.d. |
| Correspondent | King, Ph.d. SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-23 |
| Decision Date | 1987-09-14 |