K780556 is an FDA 510(k) clearance for the SPECT RIM (LISS). This device is classified as a Media, Potentiating For In Vitro Diagnostic Use (Class II - Special Controls, product code KSG).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 24, 1978, 19 days after receiving the submission on April 5, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9600.
| 510(k) Number | K780556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 1978 |
| Decision Date | April 24, 1978 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSG — Media, Potentiating For In Vitro Diagnostic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9600 |