ADAMS A1c HA-8180V, CALIBRATOR 80
FDA 510(k) K162822 · Arkray Factory, Inc.
510(k) numberK162822
Submission
- Device name
- ADAMS A1c HA-8180V, CALIBRATOR 80
- Applicant
- Arkray Factory, Inc.
Koka-Shi, JP - Received
- October 7, 2016
- Decision date
- June 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
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| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
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| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
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| K142035 | Glucocard 01-MINI Blood Glucose Monitoring System, Relion Micro Blood Glucose Monitoring…NBW · Traditional | 09/05/2014SE |
| K124021 | Arkray Glucocard 01 Blood Glucose Monitoring System and Relion Confirm Blood Glucose…CGA · Traditional | 06/30/2014SE |
Questions and answers
When was ADAMS A1c HA-8180V, CALIBRATOR 80 cleared by the FDA?
ADAMS A1c HA-8180V, CALIBRATOR 80 (K162822) received a 510(k) decision of Substantially Equivalent on June 29, 2017, 265 days after the submission was received.
What is the product code of K162822?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.