The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Urine Chemistry Control.
| Device ID | K020817 |
| 510k Number | K020817 |
| Device Name: | LIQUICHEK URINE CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-13 |
| Decision Date | 2002-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520267165 | K020817 | 000 |
| 03610520267158 | K020817 | 000 |
| 03610520267141 | K020817 | 000 |
| 00847661003458 | K020817 | 000 |
| 00847661001645 | K020817 | 000 |
| 00847661001638 | K020817 | 000 |