K923317 is an FDA 510(k) clearance for the COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL. This device is classified as a Hemoglobin A2 Quantitation (Class II - Special Controls, product code JPD).
Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 25, 1992, 49 days after receiving the submission on July 7, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7400.
| 510(k) Number | K923317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1992 |
| Decision Date | August 25, 1992 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JPD — Hemoglobin A2 Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7400 |