The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control Level 2, Model 436, Liquichek Urinalysis.
| Device ID | K031231 |
| 510k Number | K031231 |
| Device Name: | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-18 |
| Decision Date | 2003-06-18 |
| Summary: | summary |