The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Rheumatology Standard Sl.
Device ID | K964527 |
510k Number | K964527 |
Device Name: | N RHEUMATOLOGY STANDARD SL |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Contact | Ruth Forstadt |
Correspondent | Ruth Forstadt BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-12 |
Decision Date | 1997-01-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768007798 | K964527 | 000 |
00630414287409 | K964527 | 000 |