The following data is part of a premarket notification filed by Bio-rad with the FDA for Quest Diagnostics Serum Chemistry Control, Models 935 And 945.
| Device ID | K033387 |
| 510k Number | K033387 |
| Device Name: | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-23 |
| Decision Date | 2003-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520540930 | K033387 | 000 |
| 03610520540923 | K033387 | 000 |