The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Tobramycin Fluorescent Immunoassay.
| Device ID | K813542 |
| 510k Number | K813542 |
| Device Name: | TOBRAMYCIN FLUORESCENT IMMUNOASSAY |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | AMERICAN DIAGNOSTIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-21 |
| Decision Date | 1982-01-12 |