The following data is part of a premarket notification filed by Bio-rad with the FDA for Quest Diagnostics Immunoassay/tdm Control.
| Device ID | K050536 |
| 510k Number | K050536 |
| Device Name: | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 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 | 2005-03-02 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520540916 | K050536 | 000 |