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 |