Abbott ARCHITECT Free T3
FDA 510(k) K170160 · Abbott Laboratories
510(k) numberK170160
Submission
- Device name
- Abbott ARCHITECT Free T3
- Applicant
- Abbott Laboratories
Abbot Park, IL, US - Received
- January 18, 2017
- Decision date
- February 15, 2017
- 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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| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 02/17/2016SE |
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Questions and answers
When was Abbott ARCHITECT Free T3 cleared by the FDA?
Abbott ARCHITECT Free T3 (K170160) received a 510(k) decision of Substantially Equivalent on February 15, 2017, 28 days after the submission was received.
What is the product code of K170160?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.