K993321 is an FDA 510(k) clearance for the R&D HGB/GLC WHOLE BLOOD CONTROL. This device is classified as a Control, Hemoglobin (Class II - Special Controls, product code GGM).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 12, 1999, 39 days after receiving the submission on October 4, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K993321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1999 |
| Decision Date | November 12, 1999 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGM — Control, Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |