The following data is part of a premarket notification filed by Wako Pure Chemical Industries, Ltd. with the FDA for Wako Hdl Cholesterol Test.
| Device ID | K801834 |
| 510k Number | K801834 |
| Device Name: | WAKO HDL CHOLESTEROL TEST |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | WAKO PURE CHEMICAL INDUSTRIES, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-01 |
| Decision Date | 1980-09-16 |