The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Digoxin Kit.
Device ID | K812054 |
510k Number | K812054 |
Device Name: | ENDAB DIGOXIN KIT |
Classification | Enzyme Immunoassay, Digoxin |
Applicant | IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXT |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-21 |
Decision Date | 1981-08-12 |