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 |