The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Ez-bead Theophylline Enzyme Immunoassay Kit.
Device ID | K881257 |
510k Number | K881257 |
Device Name: | EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT |
Classification | Enzyme Immunoassay, Theophylline |
Applicant | IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Contact | Francis E Capitanio |
Correspondent | Francis E Capitanio IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston, MA 02134 |
Product Code | KLS |
CFR Regulation Number | 862.3880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-23 |
Decision Date | 1988-05-27 |