K051072 is an FDA 510(k) clearance for the BIO-RAD VARIANT NBS SICKLE CELL PROGRAM. 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 May 12, 2005, 16 days after receiving the submission on April 26, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K051072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2005 |
| Decision Date | May 12, 2005 |
| Days to Decision | 16 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 |