K780097 is an FDA 510(k) clearance for the QUALITY CONTROL SYSTEM, SPECTRA. This device is classified as a Kit, Quality Control For Blood Banking Reagents (Class II - Special Controls, product code KSF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 24, 1978, 95 days after receiving the submission on January 19, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9650.
| 510(k) Number | K780097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1978 |
| Decision Date | April 24, 1978 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSF — Kit, Quality Control For Blood Banking Reagents |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9650 |