The following data is part of a premarket notification filed by Wako Chemicals Usa, Inc. with the FDA for Apolowako T-cho, Hdl-c, Tg And Analyzer, Models 993-23501, 999-23601, 995-23701 And 993-25201.
| Device ID | K080125 |
| 510k Number | K080125 |
| Device Name: | APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Contact | Peter Panfili |
| Correspondent | Peter Panfili WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD Richmond, VA 23237 |
| Product Code | LBS |
| Subsequent Product Code | CDT |
| Subsequent Product Code | CGO |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-17 |
| Decision Date | 2008-07-18 |
| Summary: | summary |