The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Immunoassay Premium Control-trilevel, Liquichek Immunoassay Premium Control-level I, Liquichek Immunoassay.
| Device ID | K132227 |
| 510k Number | K132227 |
| Device Name: | LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY |
| 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 | 2013-07-17 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005193 | K132227 | 000 |
| 00847661005186 | K132227 | 000 |
| 00847661005179 | K132227 | 000 |
| 00847661005162 | K132227 | 000 |
| 00847661005155 | K132227 | 000 |