The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Hematology-16 Control Lv, Model: 295lv.
| Device ID | K091303 |
| 510k Number | K091303 |
| Device Name: | LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV |
| Classification | Mixture, Hematology Quality Control |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne S Parsons |
| Correspondent | Suzanne S Parsons Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2010-08-02 |
| Summary: | summary |