The following data is part of a premarket notification filed by Immuno Assay Corp. with the FDA for Ria Coat Digoxin.
Device ID | K833842 |
510k Number | K833842 |
Device Name: | RIA COAT DIGOXIN |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
Applicant | IMMUNO ASSAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPO |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-03 |
Decision Date | 1984-01-17 |