The following data is part of a premarket notification filed by Bio-rad, Diagnostics Grp. with the FDA for Liquichek Urinalysis Control (bi-level), Control Level1, Level 2,minipak, 435,436,437,435x.
| Device ID | K070848 |
| 510k Number | K070848 |
| Device Name: | LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Contact | Elizabeth Platt |
| Correspondent | Elizabeth Platt BIO-RAD, DIAGNOSTICS GRP. 9500 JERONIMO RD. Irvine, CA 92618 -2017 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-28 |
| Decision Date | 2007-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661003465 | K070848 | 000 |
| 00847661000563 | K070848 | 000 |
| 00847661000556 | K070848 | 000 |
| 00847661000549 | K070848 | 000 |