K090137 is an FDA 510(k) clearance for the STAK-CHEX PLUS RETICS. This device is classified as a Mixture, Control, White-cell And Red-cell Indices (Class II - Special Controls, product code GLQ).
Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on March 18, 2009, 56 days after receiving the submission on January 21, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K090137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2009 |
| Decision Date | March 18, 2009 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GLQ — Mixture, Control, White-cell And Red-cell Indices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |