The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Protein Standard Sy.
| Device ID | K952594 |
| 510k Number | K952594 |
| Device Name: | N PROTEIN STANDARD SY |
| Classification | Complement C3, Antigen, Antiserum, Control |
| 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 | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-06 |
| Decision Date | 1995-07-17 |