The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Antimicrobial Removal Device (ard).
| Device ID | K822344 |
| 510k Number | K822344 |
| Device Name: | ANTIMICROBIAL REMOVAL DEVICE (ARD) |
| Classification | Device, Antimicrobial Drug Removal |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJF |
| CFR Regulation Number | 866.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-05 |
| Decision Date | 1982-08-25 |