VARIANT II TURBO HbA1c Kit - 2.0
FDA 510(k) K142448 · Bio-Rad Laboratories, Inc.
510(k) numberK142448
Submission
- Device name
- VARIANT II TURBO HbA1c Kit - 2.0
- Applicant
- Bio-Rad Laboratories, Inc.
Hercules, CA, US - Received
- September 2, 2014
- Decision date
- March 24, 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 VARIANT II TURBO HbA1c Kit - 2.0 cleared by the FDA?
VARIANT II TURBO HbA1c Kit - 2.0 (K142448) received a 510(k) decision of Substantially Equivalent on March 24, 2015, 203 days after the submission was received.
What is the product code of K142448?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.