K770980 is an FDA 510(k) clearance for the EMATOLOGY DILUENT RESERVOIR CLOSURE. This device is classified as a Hemocytometer (Class I - General Controls, product code GHO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on July 11, 1977, 41 days after receiving the submission on May 31, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6160.
| 510(k) Number | K770980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1977 |
| Decision Date | July 11, 1977 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GHO — Hemocytometer |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6160 |