The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Aia-pack Ft4.
| Device ID | K913493 |
| 510k Number | K913493 |
| Device Name: | AIA-PACK FT4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Patricia B Shrader |
| Correspondent | Patricia B Shrader TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-06 |
| Decision Date | 1991-09-10 |