The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Multitrol Immunology Control.
| Device ID | K923663 |
| 510k Number | K923663 |
| Device Name: | MULTITROL IMMUNOLOGY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-22 |
| Decision Date | 1993-06-28 |