The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Urine Toxicology Control (confirmatory Series).
| Device ID | K033404 |
| 510k Number | K033404 |
| Device Name: | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-24 |
| Decision Date | 2003-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004042 | K033404 | 000 |
| 00847661000341 | K033404 | 000 |
| 00847661000358 | K033404 | 000 |
| 00847661000365 | K033404 | 000 |
| 00847661000372 | K033404 | 000 |
| 00847661004004 | K033404 | 000 |
| 00847661004011 | K033404 | 000 |
| 00847661004028 | K033404 | 000 |
| 00847661004035 | K033404 | 000 |
| 00847661000334 | K033404 | 000 |