The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Latex Iga.
Device ID | K952309 |
510k Number | K952309 |
Device Name: | N LATEX IGA |
Classification | Iga, Antigen, Antiserum, Control |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Nanacy M Johansen |
Correspondent | Nanacy M Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | CZP |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-17 |
Decision Date | 1995-06-20 |