K791724 is an FDA 510(k) clearance for the BIO-BAG ENVIRONMENTAL CHAMBER (A & B). This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).
Submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 48 days after receiving the submission on August 30, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.
| 510(k) Number | K791724 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1979 |
| Decision Date | October 17, 1979 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTX — Transport Systems, Anaerobic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2900 |