The following data is part of a premarket notification filed by Jay Rau, Technical Suppprt with the FDA for Kallestad Quantizyme Theophylline Enzyme.
| Device ID | K821154 |
| 510k Number | K821154 |
| Device Name: | KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | JAY RAU, TECHNICAL SUPPPRT 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 | 1982-04-26 |
| Decision Date | 1982-05-13 |