The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Maternal Serum Ii Control.
| Device ID | K143379 |
| 510k Number | K143379 |
| Device Name: | Liquichek Maternal Serum II Control |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618 |
| Contact | Elizabeth Platt |
| Correspondent | Suzanne Parsons Bio-Rad Laboratories 9500 Jeronimo Road 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 | 2014-11-25 |
| Decision Date | 2015-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520530030 | K143379 | 000 |
| 03610520530023 | K143379 | 000 |
| 03610520530016 | K143379 | 000 |
| 03610520530009 | K143379 | 000 |