Precision A1C Home HBA1C Sample Collection Kit
FDA 510(k) K983253 · Medisense, Inc.
510(k) numberK983253
Submission
- Device name
- Precision A1C Home HBA1C Sample Collection Kit
- Applicant
- Medisense, Inc.
Bedford, MA, US - Received
- September 16, 1998
- Decision date
- November 20, 1998
- 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 |
|---|---|---|
| K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…CGA · Traditional | 07/09/1999SE |
| K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System…CGA · Traditional | 12/08/1998SE |
| K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripCGA · Traditional | 08/08/1997SE |
| K963676 | Precision G Blood Glucose Testing SystemCGA · Traditional | 02/20/1997SE |
| K962295 | Precision Qid Blood Glucose Test StripCGA · Traditional | 07/26/1996SE |
| K961337 | Exactech RSG Blood Glucose Testing SystemCGA · Traditional | 06/21/1996SE |
| K952279 | Precision Link Blood Glucose Data Management SystemCGA · Traditional | 06/14/1995SE |
| K945887 | Precision Q I D Blood Glucose Test StripsCGA · Traditional | 03/23/1995SE |
| K944195 | Quickpro Blood Glucose Testing SystemCGA · Traditional | 03/23/1995SE |
| K901613 | Medisense Pen 2/COMPANION 2 Blood Glucose SystemCGA · Traditional | 07/10/1990SE |
Questions and answers
When was Precision A1C Home HBA1C Sample Collection Kit cleared by the FDA?
Precision A1C Home HBA1C Sample Collection Kit (K983253) received a 510(k) decision of Substantially Equivalent on November 20, 1998, 65 days after the submission was received.
What is the product code of K983253?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.