K051633 is an FDA 510(k) clearance for the CD-CHEX PLUS BC. This device is classified as a Control, White-cell (Class II - Special Controls, product code GGL).
Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on August 16, 2005, 57 days after receiving the submission on June 20, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K051633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2005 |
| Decision Date | August 16, 2005 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGL — Control, White-cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |