The following data is part of a premarket notification filed by Solomon Park Research Laboratories with the FDA for Qc3 Whole Human Serum, Hdl-cholesterol Control.
| Device ID | K872078 |
| 510k Number | K872078 |
| Device Name: | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | SOLOMON PARK RESEARCH LABORATORIES 12815 NE 124TH ST., SUITE "I" Kirkland, WA 98034 |
| Contact | Joan Corbett-clapsha |
| Correspondent | Joan Corbett-clapsha SOLOMON PARK RESEARCH LABORATORIES 12815 NE 124TH ST., SUITE "I" Kirkland, WA 98034 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-29 |
| Decision Date | 1987-06-18 |