K781330 is an FDA 510(k) clearance for the BLOOD LEVEL DETECTOR-MODEL 7601. This device is classified as a Detector, Air Bubble (Class II - Special Controls, product code FJF).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 31, 1978, 29 days after receiving the submission on August 2, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K781330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1978 |
| Decision Date | August 31, 1978 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | FJF — Detector, Air Bubble |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |