The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Nephelometer Ii.
| Device ID | K943997 |
| 510k Number | K943997 |
| Device Name: | BEHRING NEPHELOMETER II |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | DEW |
| Subsequent Product Code | CFQ |
| Subsequent Product Code | CZP |
| Subsequent Product Code | DCH |
| Subsequent Product Code | GTQ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-16 |
| Decision Date | 1994-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012174 | K943997 | 000 |
| 00842768012167 | K943997 | 000 |
| 00630414002903 | K943997 | 000 |