K810591 is an FDA 510(k) clearance for the PACT SUPPLEMENT. This device is classified as a Supplement, Culture Media (Class I - General Controls, product code JSK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 20, 1981, 15 days after receiving the submission on March 5, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2450.
| 510(k) Number | K810591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1981 |
| Decision Date | March 20, 1981 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSK — Supplement, Culture Media |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2450 |