Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
FDA 510(k) K140654 · Abbott Laboratories
510(k) numberK140654
Submission
- Device name
- Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 14, 2014
- Decision date
- May 22, 2015
- 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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Questions and answers
When was Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls cleared by the FDA?
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls (K140654) received a 510(k) decision of Substantially Equivalent on May 22, 2015, 434 days after the submission was received.
What is the product code of K140654?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.