The following data is part of a premarket notification filed by Bioclinical Corp. with the FDA for Bio-mag Theophylline (125i) Radioimmun..
| Device ID | K821347 |
| 510k Number | K821347 |
| Device Name: | BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. |
| Classification | Radioimmunoassay, Theophylline |
| Applicant | BIOCLINICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCA |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-05 |
| Decision Date | 1982-05-28 |