The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Immunoassay Drugs Of Abuse Controls.
| Device ID | K952056 |
| 510k Number | K952056 |
| Device Name: | IMMUNOASSAY DRUGS OF ABUSE CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | MEDI-TECH, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick MEDI-TECH, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1995-06-01 |