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 |