The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Tobramycin Assay.
| Device ID | K903192 |
| 510k Number | K903192 |
| Device Name: | IL TOBRAMYCIN ASSAY |
| Classification | Radioimmunoassay, Tobramycin |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Contact | George A Lyna |
| Correspondent | George A Lyna INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Product Code | KLB |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-19 |
| Decision Date | 1990-08-22 |