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FDA 510(k)

ImmunoCard STAT! HpSA

K-Number: K153661 · 2016-03-14

ApplicantMeridian Bioscience, Inc.
Decision Date2016-03-14
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ImmunoCard STAT! HpSA is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2016-03-14 under approval number K153661. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmunoCard STAT! HpSA?

ImmunoCard STAT! HpSA is a medical device that received FDA 510(k) clearance on 2016-03-14. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K153661.

When was ImmunoCard STAT! HpSA approved by the FDA?

ImmunoCard STAT! HpSA received FDA 510(k) clearance on 2016-03-14, under approval number K153661.

What company makes ImmunoCard STAT! HpSA?

ImmunoCard STAT! HpSA is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for ImmunoCard STAT! HpSA?

The FDA product code for ImmunoCard STAT! HpSA is LYR.

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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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