The following data is part of a premarket notification filed by Toxi-lab, Inc. with the FDA for Alpha Urine Sample.
| Device ID | K900626 |
| 510k Number | K900626 |
| Device Name: | ALPHA URINE SAMPLE |
| Classification | Drug Mixture Control Materials |
| Applicant | TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Contact | Michael O'donnell |
| Correspondent | Michael O'donnell TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-08 |
| Decision Date | 1990-03-06 |