The following data is part of a premarket notification filed by Beckman Coulter Inc. with the FDA for Dxc 700 Au Clinical Chemistry Analyzer, Au Igg Reagent.
| Device ID | K162208 |
| 510k Number | K162208 |
| Device Name: | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Contact | Geraldine Fuentespina |
| Correspondent | Geraldine Fuentespina BECKMAN COULTER INC. 250 S. KRAEMER BLVD. MAIL STOP E1.SE.01 Brea, CA 92821 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-01-09 |
| Summary: | summary |