The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Magic 125i Digoxin Radioimmunoassay.
Device ID | K840461 |
510k Number | K840461 |
Device Name: | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY |
Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Solid Phase Sep. |
Applicant | CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DON |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-02 |
Decision Date | 1984-03-23 |