The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Tdm Control.
| Device ID | K012741 |
| 510k Number | K012741 |
| Device Name: | LIQUICHEK TDM CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001942 | K012741 | 000 |
| 00847661001362 | K012741 | 000 |
| 00847661001355 | K012741 | 000 |
| 00847661001348 | K012741 | 000 |
| 00847661001331 | K012741 | 000 |