The following data is part of a premarket notification filed by Quantimetrix Medical Industries with the FDA for Lipophor(tm) Syst, Human Serum Lipoprotein Control.
| Device ID | K883247 |
| 510k Number | K883247 |
| Device Name: | LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Contact | Ernest S Johnson |
| Correspondent | Ernest S Johnson QUANTIMETRIX MEDICAL INDUSTRIES 11953 SOUTH PRAIRIE AVE. Hawthorne, CA 90250 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-02 |
| Decision Date | 1988-09-13 |