The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Urine Toxicology Control (level C1).
| Device ID | K050682 |
| 510k Number | K050682 |
| Device Name: | LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) |
| 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 | 2005-03-16 |
| Decision Date | 2005-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003991 | K050682 | 000 |
| 00847661000327 | K050682 | 000 |