The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Quinidine Fluorescent Immunoassay.
| Device ID | K832493 |
| 510k Number | K832493 |
| Device Name: | QUINIDINE FLUORESCENT IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Quinidine |
| Applicant | AMERICAN DIAGNOSTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBZ |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-27 |
| Decision Date | 1983-09-12 |