The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Quest Diagnostics Serum Chemistry Control, Models 935 And 945.
| Device ID | K073080 |
| 510k Number | K073080 |
| Device Name: | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos Bio-Rad Laboratories 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 | 2007-10-31 |
| Decision Date | 2008-01-24 |
| Summary: | summary |