The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus Control, Level 2 Model 268, Liquichek.
| Device ID | K122838 |
| 510k Number | K122838 |
| Device Name: | LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons Bio-Rad Laboratories 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 | 2012-09-17 |
| Decision Date | 2012-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004127 | K122838 | 000 |
| 00847661004110 | K122838 | 000 |
| 00847661004103 | K122838 | 000 |
| 00847661004097 | K122838 | 000 |