The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Bio-bag Tm Environmental Chamber Type M.
| Device ID | K811067 |
| 510k Number | K811067 |
| Device Name: | BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M |
| Classification | Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZT |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-17 |
| Decision Date | 1981-04-29 |