The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquid Assayed Multiqual Control.
| Device ID | K043208 |
| 510k Number | K043208 |
| Device Name: | LIQUID ASSAYED MULTIQUAL CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. 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 | 2004-11-19 |
| Decision Date | 2005-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001928 | K043208 | 000 |
| 00847661001294 | K043208 | 000 |
| 00847661001287 | K043208 | 000 |
| 00847661001270 | K043208 | 000 |