The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Detection Of Theophylline.
| Device ID | K821544 |
| 510k Number | K821544 |
| Device Name: | DETECTION OF THEOPHYLLINE |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-24 |
| Decision Date | 1982-06-10 |