The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Amerifluor Theophylline Fluorescent Imm.
| Device ID | K820397 |
| 510k Number | K820397 |
| Device Name: | AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM |
| Classification | Fluorescent Immunoassay, Theophylline |
| Applicant | AMERICAN DIAGNOSTIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LER |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-11 |
| Decision Date | 1982-03-02 |