The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Elevated Crp Control.
| Device ID | K042837 |
| 510k Number | K042837 |
| Device Name: | LIQUICHEK ELEVATED CRP CONTROL |
| Classification | Single (specified) Analyte 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-14 |
| Decision Date | 2004-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001768 | K042837 | 000 |
| 00847661000938 | K042837 | 000 |
| 00847661000921 | K042837 | 000 |
| 00847661000914 | K042837 | 000 |