The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak.
| Device ID | K120504 |
| 510k Number | K120504 |
| Device Name: | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD LABORATORIES, INC. 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 | 2012-02-21 |
| Decision Date | 2012-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004844 | K120504 | 000 |
| 00847661004837 | K120504 | 000 |
| 00847661004820 | K120504 | 000 |
| 00847661004813 | K120504 | 000 |
| 00847661004806 | K120504 | 000 |
| 00847661004790 | K120504 | 000 |
| 00847661004691 | K120504 | 000 |
| 00847661004677 | K120504 | 000 |