Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Philosys Co., Ltd. with 5 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Jan 14, 2020: Warning letter: Stability, Complaint handling, MDR reporting.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 14, 2020 | Warning letter: Stability, Complaint handling, MDR reportingCDRH | Warning letters |
| Dec 1, 2015 | Gmate Origin Blood Glucose Monitoring SystemK151658 · NBW | 510(k) clearances |
| Nov 19, 2015 | Gmate SMART Blood Glucose Monitoring SystemK150299 · NBW | 510(k) clearances |
| Oct 2, 2015 | GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEMK141656 · NBW | 510(k) clearances |
| Aug 4, 2014 | GMATE SMART BLOOD GLUCOSE MONITORING SYSTEM, GMATE SMART APPLICATIONK131230 · NBW | 510(k) clearances |
| Mar 8, 2013 | BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)K113636 · CGA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
