The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Crp Standard Sy.
| Device ID | K962406 |
| 510k Number | K962406 |
| Device Name: | N CRP STANDARD SY |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons 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 | 1996-06-21 |
| Decision Date | 1996-07-16 |
| Summary: | summary |