The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek D-dimer Control Level 1, 2 And 3.
| Device ID | K032017 |
| 510k Number | K032017 |
| Device Name: | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 |
| Classification | Plasma, Coagulation Control |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Contact | Maria Zeballos |
| Correspondent | Maria Zeballos BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661004516 | K032017 | 000 |
| 00847661004509 | K032017 | 000 |
| 00847661004493 | K032017 | 000 |
| 00847661004486 | K032017 | 000 |
| 00847661004479 | K032017 | 000 |