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 |