Abbott ARCHITECT Total T4 Calibrators
FDA 510(k) K151566 · Abbott Laboratories
510(k) numberK151566
Submission
- Device name
- Abbott ARCHITECT Total T4 Calibrators
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- June 10, 2015
- Decision date
- July 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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Questions and answers
When was Abbott ARCHITECT Total T4 Calibrators cleared by the FDA?
Abbott ARCHITECT Total T4 Calibrators (K151566) received a 510(k) decision of Substantially Equivalent on July 10, 2015, 30 days after the submission was received.
What is the product code of K151566?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.