K972404 is an FDA 510(k) clearance for the VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE). This device is classified as a Flask, Tissue Culture (Class I - General Controls, product code KJA).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on July 22, 1997, 26 days after receiving the submission on June 26, 1997.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K972404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1997 |
| Decision Date | July 22, 1997 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | Summary PDF |
| Product Code | KJA — Flask, Tissue Culture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2240 |