K990553 is an FDA 510(k) clearance for the IGM FLEX REAGENT CARTRIDGE. This device is classified as a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFQ).
Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 22, 1999, 28 days after receiving the submission on February 22, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K990553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1999 |
| Decision Date | March 22, 1999 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CFQ — Radioimmunoassay, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |