The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for In Vitro Theophylline Ria Test.
| Device ID | K772017 |
| 510k Number | K772017 |
| Device Name: | IN VITRO THEOPHYLLINE RIA TEST |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | CLINICAL ASSAYS, 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 | 1977-10-26 |
| Decision Date | 1978-03-27 |