K800539 is an FDA 510(k) clearance for the DISP. HYDROGEN & CO2 GENERATOR ENVELOPE. This device is classified as a Device, Gas Generating (Class I - General Controls, product code KZJ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 8, 1980, 29 days after receiving the submission on March 10, 1980.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2580.
| 510(k) Number | K800539 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1980 |
| Decision Date | April 08, 1980 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KZJ — Device, Gas Generating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2580 |