The following data is part of a premarket notification filed by Clinical Controls Division with the FDA for Liquispx Liquid Lipid Control.
| Device ID | K012855 |
| 510k Number | K012855 |
| Device Name: | LIQUISPX LIQUID LIPID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINICAL CONTROLS DIVISION 12038 CENTRALIA AVE. UNIT C Hawaiian Gardens, CA 90716 |
| Contact | James F Godfrey |
| Correspondent | James F Godfrey CLINICAL CONTROLS DIVISION 12038 CENTRALIA AVE. UNIT C Hawaiian Gardens, CA 90716 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-24 |
| Decision Date | 2001-08-30 |