The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (igmlc) Reagent, Beckman Coulter Cereb.
| Device ID | K993547 |
| 510k Number | K993547 |
| Device Name: | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Richard T Ross |
| Correspondent | Richard T Ross BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 2000-02-01 |
| Summary: | summary |