The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Ez-bead Digoxin Eia Kit.
Device ID | K893843 |
510k Number | K893843 |
Device Name: | EZ-BEAD DIGOXIN EIA KIT |
Classification | Enzyme Immunoassay, Digoxin |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | Francis Capitanio |
Correspondent | Francis Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | KXT |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-25 |
Decision Date | 1989-09-28 |