The following data is part of a premarket notification filed by Toxi-lab, Inc. with the FDA for Toxi*lab Ltd Opiate System.
| Device ID | K932209 |
| 510k Number | K932209 |
| Device Name: | TOXI*LAB LTD OPIATE SYSTEM |
| Classification | Thin Layer Chromatography, Opiates |
| Applicant | TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Contact | Lorna Gamboa |
| Correspondent | Lorna Gamboa TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Product Code | LAI |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-06 |
| Decision Date | 1993-09-24 |