The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Lyphochek Whole Blood Control, Models 561, 562, 563.
| Device ID | K022041 |
| 510k Number | K022041 |
| Device Name: | LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos 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 | 2002-06-24 |
| Decision Date | 2002-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001867 | K022041 | 000 |
| 00847661001676 | K022041 | 000 |
| 00847661001669 | K022041 | 000 |
| 00847661001652 | K022041 | 000 |