The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bio-bag Environmental Chamber -type A-multi-plate.
| Device ID | K845008 |
| 510k Number | K845008 |
| Device Name: | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE |
| Classification | Device, Gas Generating |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | William H Guinty |
| Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-03-05 |