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 | K964687 |
| 510k Number | K964687 |
| Device Name: | N LATEX CRP MONO REAGENT |
| Classification | System, Test, C-reactive Protein, Rhodamine |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Laura Lebarron |
| Correspondent | Laura Lebarron BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | DCH |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1996-12-16 |
| Summary: | summary |