The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Opiate Control.
| Device ID | K093577 |
| 510k Number | K093577 |
| Device Name: | LIQUICHEK OPIATE CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt Bio-Rad Laboratories 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 | 2009-11-18 |
| Decision Date | 2010-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003496 | K093577 | 000 |
| 00847661003489 | K093577 | 000 |
| 00847661003472 | K093577 | 000 |