The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Lyphochek Tumor Market Plus Control Level 1, 2 And 3 And Minipak.
| Device ID | K082036 |
| 510k Number | K082036 |
| Device Name: | LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt Bio-Rad Laboratories 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 | 2008-07-17 |
| Decision Date | 2008-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003403 | K082036 | 000 |
| 00847661001430 | K082036 | 000 |
| 00847661001423 | K082036 | 000 |
| 00847661001416 | K082036 | 000 |