D-10 Hemoglobin A1c Program
FDA 510(k) K161687 · Bio-Rad Laboratories, Inc.
510(k) numberK161687
Submission
- Device name
- D-10 Hemoglobin A1c Program
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- June 17, 2016
- Decision date
- October 14, 2016
- 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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| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
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| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
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Questions and answers
When was D-10 Hemoglobin A1c Program cleared by the FDA?
D-10 Hemoglobin A1c Program (K161687) received a 510(k) decision of Substantially Equivalent on October 14, 2016, 119 days after the submission was received.
What is the product code of K161687?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.