K090093 is an FDA 510(k) clearance for the STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 10, 2009, 147 days after receiving the submission on January 14, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K090093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2009 |
| Decision Date | June 10, 2009 |
| Days to Decision | 147 days |
| Submission Type | Special |
| 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 |