The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Ez-bead Phenytoin Enzyme Immunoassay Kit.
Device ID | K901080 |
510k Number | K901080 |
Device Name: | EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT |
Classification | Enzyme Immunoassay, Diphenylhydantoin |
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 | DIP |
CFR Regulation Number | 862.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-07 |
Decision Date | 1990-05-17 |