The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Rheumatology Control Sl/1, Sl/2.
| Device ID | K944375 |
| 510k Number | K944375 |
| Device Name: | N/T RHEUMATOLOGY CONTROL SL/1, SL/2 |
| Classification | C-reactive Protein, Antigen, Antiserum, And 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1994-10-03 |