The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for Liquichek Urine Chemistry Control.
| Device ID | K121794 |
| 510k Number | K121794 |
| Device Name: | LIQUICHEK URINE CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons BIO-RAD, DIAGNOSTICS GRP. 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 | 2012-06-19 |
| Decision Date | 2012-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004363 | K121794 | 000 |
| 00847661004356 | K121794 | 000 |
| 00847661004349 | K121794 | 000 |