The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Micro Dau Opiate Enzyme Immunoassay Kit.
| Device ID | K902194 |
| 510k Number | K902194 |
| Device Name: | MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Contact | E Capitanio |
| Correspondent | E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-07-17 |