The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Latex Ferritin.
Device ID | K950707 |
510k Number | K950707 |
Device Name: | N LATEX FERRITIN |
Classification | Ferritin, Antigen, Antiserum, Control |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Kathleen Dray-lyons |
Correspondent | Kathleen Dray-lyons BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | DBF |
CFR Regulation Number | 866.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-15 |
Decision Date | 1995-03-27 |