The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Liquichek Torch Plus Igm Control.
| Device ID | K040822 |
| 510k Number | K040822 |
| Device Name: | LIQUICHEK TORCH PLUS IGM CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Keballos |
| Correspondent | Maria Keballos 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 | 2004-03-30 |
| Decision Date | 2004-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661000518 | K040822 | 000 |
| 00847661000501 | K040822 | 000 |
| 00847661000273 | K040822 | 000 |
| 00847661000266 | K040822 | 000 |