The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Iga Minineph Antiserum.
Device ID | K981786 |
510k Number | K981786 |
Device Name: | IGA MININEPH ANTISERUM |
Classification | Radioimmunoassay, Immunoglobulins (g, A, M) |
Applicant | THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
Contact | Jay H Geller |
Correspondent | Jay H Geller THE BINDING SITE, LTD. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
Product Code | CFQ |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-20 |
Decision Date | 1999-11-24 |