The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2, Liquichek Spinal Fluid Control Minipak.
| Device ID | K123775 |
| 510k Number | K123775 |
| Device Name: | LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | Bio-Rad Laboratories 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Suzanne Parsons |
| Correspondent | Suzanne Parsons 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 | 2012-12-10 |
| Decision Date | 2013-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005063 | K123775 | 000 |
| 00847661005056 | K123775 | 000 |
| 00847661005049 | K123775 | 000 |