The following data is part of a premarket notification filed by California Immuno Diagnostic, Inc. with the FDA for Autofluor System.
| Device ID | K800698 |
| 510k Number | K800698 |
| Device Name: | AUTOFLUOR SYSTEM |
| Classification | Fluorometer |
| Applicant | CALIFORNIA IMMUNO DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JZT |
| CFR Regulation Number | 866.4520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-28 |
| Decision Date | 1980-05-28 |