K171664 is an FDA 510(k) clearance for the Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software. This device is classified as a Abnormal Hemoglobin Quantitation (Class II - Special Controls, product code GKA).
Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on September 13, 2017, 100 days after receiving the submission on June 5, 2017.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K171664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2017 |
| Decision Date | September 13, 2017 |
| Days to Decision | 100 days |
| Submission Type | Special |
| 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 |