The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Latex B2-microglobulin Reagent.
| Device ID | K955596 |
| 510k Number | K955596 |
| Device Name: | N LATEX B2-MICROGLOBULIN REAGENT |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| 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 | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-08 |
| Decision Date | 1996-10-03 |
| Summary: | summary |