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 |