The following data is part of a premarket notification filed by Allergenetics with the FDA for Theofast Test Kit For Quantitative Theo.
| Device ID | K834244 |
| 510k Number | K834244 |
| Device Name: | THEOFAST TEST KIT FOR QUANTITATIVE THEO |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | ALLERGENETICS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-07 |
| Decision Date | 1984-01-24 |