The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Microzyme Thc Enzyme Immunoassay Test Kit.
| Device ID | K904635 |
| 510k Number | K904635 |
| Device Name: | MICROZYME THC ENZYME IMMUNOASSAY TEST KIT |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-11-01 |