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 |