K192931 is an FDA 510(k) clearance for the V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control. This device is classified as a Abnormal Hemoglobin Quantitation (Class II - Special Controls, product code GKA).
Submitted by Helena Laboratories, Corp. (Beaumont, US). The FDA issued a Cleared decision on April 19, 2022, 915 days after receiving the submission on October 17, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K192931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2019 |
| Decision Date | April 19, 2022 |
| Days to Decision | 915 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKA - Abnormal Hemoglobin Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7415 |