The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquicheck Urine Toxicology Negative Control.
| Device ID | K970666 |
| 510k Number | K970666 |
| Device Name: | LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 3726 EAST MIRALOMA AVE. Anaheim, CA 92806 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-24 |
| Decision Date | 1997-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661002062 | K970666 | 000 |
| 00847661000303 | K970666 | 000 |