The following data is part of a premarket notification filed by Lite-on Technology Corp. H.s.p.b. with the FDA for Comprehensive Metabolic Panel, Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer.
| Device ID | K171971 |
| 510k Number | K171971 |
| Device Name: | Comprehensive Metabolic Panel, Skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Applicant | Lite-On Technology Corp. H.S.P.B. 8, Dusing Road, Hsinchu Science Park Hsinchu City, TW 30078 |
| Contact | John Lo |
| Correspondent | Feng-yu Lee Dynamic Biotech, Inc. Dba IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675 |
| Product Code | CJE |
| Subsequent Product Code | CDN |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CKA |
| Subsequent Product Code | JJG |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2018-01-25 |
| Summary: | summary |