Ixensor Co Ltd
Taipei, TW
IXENSOR CO LTD appears in FDA device records in Taipei, TW. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Ixensor Co Ltd between 2017 and 2019. The busiest year on record is 2019, with 2. The most recent is 2019, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | LCP | Substantially Equivalent | |
| K163087 | PixoTest Blood Glucose Monitoring System | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011061417 | 3011061417 | IXENSOR CO LTD | 11492 6F., No.9, Aly. 2, Ln. 35, Jihu Rd.,, Taipei 114 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- JGYColorimetric Method, Triglycerides
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- LBRLdl & Vldl Precipitation, Hdl
- NBWSystem, Test, Blood Glucose, Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- MNRVentilatory Effort Recorder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain