K122553 is an FDA 510(k) clearance for the MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2013, 349 days after receiving the submission on August 21, 2012.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K122553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2012 |
| Decision Date | August 05, 2013 |
| Days to Decision | 349 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKR — System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |