The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Latex Crp Mono Reagent.
| Device ID | K962523 |
| 510k Number | K962523 |
| Device Name: | N LATEX CRP MONO REAGENT |
| 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 | 1996-05-30 |
| Decision Date | 1996-07-10 |
| Summary: | summary |