The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Liquichek Ethanol/ammonia Control Level 1 Model 271, Liquichek Ethanol/ammonia Control Level 2 Model 272, Liquichek Etha.
| Device ID | K123198 |
| 510k Number | K123198 |
| Device Name: | LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA |
| 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 | 2012-10-11 |
| Decision Date | 2012-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847661005100 | K123198 | 000 |
| 00847661005094 | K123198 | 000 |
| 00847661005087 | K123198 | 000 |
| 00847661005070 | K123198 | 000 |