The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Lyphochek Assayed Chemistry Control.
| Device ID | K040273 |
| 510k Number | K040273 |
| Device Name: | LYPHOCHEK ASSAYED CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD LABORATORIES, INC. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt 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 | 2004-02-05 |
| Decision Date | 2004-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001973 | K040273 | 000 |
| 00847661000761 | K040273 | 000 |
| 00847661000754 | K040273 | 000 |