The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme(tm) Free T4 Enzyme Immunoassay Test.
| Device ID | K911634 |
| 510k Number | K911634 |
| Device Name: | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Contact | Francis E Capitanio |
| Correspondent | Francis E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-06-24 |