K770185 is an FDA 510(k) clearance for the RH CONTROL DILUENT. This device is classified as a System, Test, Automated Blood Grouping And Antibody (Class II - Special Controls, product code KSZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 14, 1977, 46 days after receiving the submission on January 27, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9175.
| 510(k) Number | K770185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1977 |
| Decision Date | March 14, 1977 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSZ — System, Test, Automated Blood Grouping And Antibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9175 |