The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Digoctk 125.
Device ID | K800773 |
510k Number | K800773 |
Device Name: | DIGOCTK 125 |
Classification | Radioimmunoassay, Digoxin (125-i) |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LCS |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-07 |
Decision Date | 1980-04-24 |