K802266 is an FDA 510(k) clearance for the HGB3 (1:251). This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 23, 1980, 37 days after receiving the submission on September 16, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K802266 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 1980 |
| Decision Date | October 23, 1980 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKR — System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |