K800796 is an FDA 510(k) clearance for the GAS PAK II DIS. GENERATOR ENVELOPES. 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 24, 1980, 15 days after receiving the submission on April 9, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.2580.
| 510(k) Number | K800796 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1980 |
| Decision Date | April 24, 1980 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KZJ — Device, Gas Generating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2580 |