The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for N Latex B2-microglobulin.
| Device ID | K002731 |
| 510k Number | K002731 |
| Device Name: | N LATEX B2-MICROGLOBULIN |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | DADE BEHRING, INC. 7739 NW 48 ST. SUITE 120 Miami, FL 33166 |
| Contact | Radames Riesgo |
| Correspondent | Radames Riesgo DADE BEHRING, INC. 7739 NW 48 ST. SUITE 120 Miami, FL 33166 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-01 |
| Decision Date | 2000-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768008429 | K002731 | 000 |