The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for Aia-pack T4.
| Device ID | K896982 |
| 510k Number | K896982 |
| Device Name: | AIA-PACK T4 |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | M Holstein |
| Correspondent | M Holstein TOSOH CORP. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-19 |
| Decision Date | 1990-03-09 |