The following data is part of a premarket notification filed by Allied Instrumentation Laboratory with the FDA for Il Test Theophylline Assay.
| Device ID | K853858 |
| 510k Number | K853858 |
| Device Name: | IL TEST THEOPHYLLINE ASSAY |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | George A Lyna |
| Correspondent | George A Lyna ALLIED INSTRUMENTATION LABORATORY 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-16 |
| Decision Date | 1985-10-15 |