K993547 is an FDA 510(k) clearance for the BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB. This device is classified as a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFN).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 1, 2000, 105 days after receiving the submission on October 19, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K993547 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1999 |
| Decision Date | February 01, 2000 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFN — Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |