URight Hemoglobin A1c system, FORA A1c System
FDA 510(k) K142664 · Taidoc Technology Corporation
510(k) numberK142664
Submission
- Device name
- URight Hemoglobin A1c system, FORA A1c System
- Applicant
- Taidoc Technology Corporation
New Taipei City, TW - Received
- September 18, 2014
- Decision date
- January 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
Other 510(k)s with product code LCP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track | 11/19/2024SE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional | 06/16/2022SE |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional | 04/05/2022SE |
| K190579 | TD-4183 Blood Glucose Monitoring SystemNBW · Traditional | 06/04/2019SE |
| K182934 | FORA P100 Blood Pressure Monitoring SystemDXN · Traditional | 02/12/2019SE |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional | 12/19/2018SE |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemPTC · Traditional | 12/10/2018SE |
| K181588 | POPS! one Blood Glucose Monitoring SystemNBW · Traditional | 11/30/2018SE |
| K172733 | TD-1035 ThermometerFLL · Traditional | 10/22/2018SE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special | 07/12/2018SE |
Questions and answers
When was URight Hemoglobin A1c system, FORA A1c System cleared by the FDA?
URight Hemoglobin A1c system, FORA A1c System (K142664) received a 510(k) decision of Substantially Equivalent on January 29, 2016, 498 days after the submission was received.
What is the product code of K142664?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.