The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Digitoxin Enzyme Immunoassay Kit.
Device ID | K802461 |
510k Number | K802461 |
Device Name: | ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT |
Classification | Radioimmunoassay, Digitoxin (125-i) |
Applicant | IMMUNOTECH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LCW |
CFR Regulation Number | 862.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-08 |
Decision Date | 1980-10-31 |