K060130 is an FDA 510(k) clearance for the IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT. This device is classified as a Iga, Antigen, Antiserum, Control (Class II - Special Controls, product code CZP).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 13, 2006, 26 days after receiving the submission on January 18, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K060130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2006 |
| Decision Date | February 13, 2006 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CZP — Iga, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |