The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Specialty Immunoassay Control.
| Device ID | K043108 |
| 510k Number | K043108 |
| Device Name: | LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne S Parsons |
| Correspondent | Suzanne S Parsons BIO-RAD LABORATORIES, INC. 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 | 2004-11-09 |
| Decision Date | 2004-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001799 | K043108 | 000 |
| 00847661001577 | K043108 | 000 |
| 00847661001560 | K043108 | 000 |
| 00847661001553 | K043108 | 000 |
| 00847661001546 | K043108 | 000 |