The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Urine Toxicology Control, (levels S1s And S2s).
| Device ID | K042865 |
| 510k Number | K042865 |
| Device Name: | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne S Parsons |
| Correspondent | Suzanne S Parsons BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-18 |
| Decision Date | 2004-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003946 | K042865 | 000 |
| 00847661003939 | K042865 | 000 |
| 00847661000440 | K042865 | 000 |
| 00847661000433 | K042865 | 000 |