K920997 is an FDA 510(k) clearance for the CD-CHEX. This device is classified as a Control, White-cell (Class II - Special Controls, product code GGL).
Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on May 31, 1992, 90 days after receiving the submission on March 2, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K920997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1992 |
| Decision Date | May 31, 1992 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGL — Control, White-cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |