The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bio-bag Environmental Chamber (a & B).
| Device ID | K791724 |
| 510k Number | K791724 |
| Device Name: | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) |
| Classification | Transport Systems, Anaerobic |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTX |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-08-30 |
| Decision Date | 1979-10-17 |