The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Tumor Marker Control-level 1; Liquichek Tumor Marker Control-level 2; Liquichek Tumor Marker Control-level 3; Liquichek Tumor Marker Control- Trilevel Minipak.
| Device ID | K163015 |
| 510k Number | K163015 |
| Device Name: | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES 9500 JERONIMO ROAD Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Suzanne Parsons BIO-RAD LABORATORIES 9500 JERONIMO ROAD 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 | 2016-10-28 |
| Decision Date | 2017-01-10 |
| Summary: | summary |