The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Toxi-lab Rapid Screen.
| Device ID | K823523 |
| 510k Number | K823523 |
| Device Name: | TOXI-LAB RAPID SCREEN |
| Classification | Colorimetry, Salicylate |
| Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-29 |
| Decision Date | 1983-01-14 |