The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme Unconjugated Estriol Enzyme Immuno Kit.
| Device ID | K903359 |
| 510k Number | K903359 |
| Device Name: | MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT |
| Classification | Radioimmunoassay, Estriol |
| 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 | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-08-22 |