The following data is part of a premarket notification filed by Bio-rad with the FDA for Liquichek Immunology Control Level 1, 2, And 3-1 Ml, Model 591, 592, 593; Level 1, 2, And 3-3 Ml, Model 594, 595, 596.
| Device ID | K022991 |
| 510k Number | K022991 |
| Device Name: | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661001874 | K022991 | 000 |
| 03610520174364 | K022991 | 000 |
| 03610520174371 | K022991 | 000 |
| 03610520174388 | K022991 | 000 |
| 00847661001157 | K022991 | 000 |
| 00847661001164 | K022991 | 000 |
| 00847661001171 | K022991 | 000 |
| 00847661001188 | K022991 | 000 |
| 00847661001195 | K022991 | 000 |
| 00847661001201 | K022991 | 000 |
| 03610520174357 | K022991 | 000 |