The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363.
| Device ID | K001373 |
| 510k Number | K001373 |
| Device Name: | LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIO-RAD 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD 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 | 2000-05-01 |
| Decision Date | 2000-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03610520267332 | K001373 | 000 |
| 03610520267325 | K001373 | 000 |
| 03610520267318 | K001373 | 000 |
| 03610520267301 | K001373 | 000 |
| 00847661001775 | K001373 | 000 |
| 00847661001140 | K001373 | 000 |
| 00847661001133 | K001373 | 000 |
| 00847661001126 | K001373 | 000 |
| 00847661001119 | K001373 | 000 |