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FDA 510(k)

ARCHITECT STAT High Sensitivity Troponin-I

K-Number: K191595 · 2019-09-13

ApplicantAbbott Laboratories Diagnostics Division
Decision Date2019-09-13
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT STAT High Sensitivity Troponin-I is a medical device manufactured by Abbott Laboratories Diagnostics Division. It received FDA 510(k) clearance on 2019-09-13 under approval number K191595. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT STAT High Sensitivity Troponin-I?

ARCHITECT STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Abbott Laboratories Diagnostics Division. The 510(k) number is K191595.

When was ARCHITECT STAT High Sensitivity Troponin-I approved by the FDA?

ARCHITECT STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2019-09-13, under approval number K191595.

What company makes ARCHITECT STAT High Sensitivity Troponin-I?

ARCHITECT STAT High Sensitivity Troponin-I is manufactured by Abbott Laboratories Diagnostics Division.

What is the FDA product code for ARCHITECT STAT High Sensitivity Troponin-I?

The FDA product code for ARCHITECT STAT High Sensitivity Troponin-I is MMI.

Other Devices by Abbott Laboratories Diagnostics Division

K202525Alinity i STAT High Sensitivity Troponin-I K230994Alinity i STAT High Sensitivity Troponin-I K240468Alkaline Phosphatase

Related Devices (Code: MMI)

K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5Roche Diagnostics K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K172787Access hsTnlBeckman Coulter, Inc. K172783Access hs TnlBeckman Coulter, Inc. K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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