The following data is part of a premarket notification filed by Pcl-ria, Inc. with the FDA for Digoxin Kit.
Device ID | K823014 |
510k Number | K823014 |
Device Name: | DIGOXIN KIT |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
Applicant | PCL-RIA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPB |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-13 |
Decision Date | 1982-11-01 |