The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Reference Preparation For Proteins In Human Serum.
| Device ID | K922646 |
| 510k Number | K922646 |
| Device Name: | REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM |
| Classification | Calibrator, Primary |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | Joseph Kiceina |
| Correspondent | Joseph Kiceina BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1993-06-25 |