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FDA 510(k)

DESTINY MAX COAGULATION ANALYZER

K-Number: K083896 · 2009-07-02

ApplicantTrinity Biotech
Decision Date2009-07-02
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DESTINY MAX COAGULATION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech. It received FDA 510(k) clearance on 2009-07-02 under 510(k) number K083896. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DESTINY MAX COAGULATION ANALYZER?

DESTINY MAX COAGULATION ANALYZER is a medical device that received FDA 510(k) clearance on 2009-07-02. The listed applicant is Trinity Biotech. The 510(k) number is K083896.

When did DESTINY MAX COAGULATION ANALYZER receive FDA 510(k) clearance?

DESTINY MAX COAGULATION ANALYZER received FDA 510(k) clearance on 2009-07-02, under 510(k) number K083896.

Who is the listed applicant for DESTINY MAX COAGULATION ANALYZER?

The FDA 510(k) record lists Trinity Biotech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DESTINY MAX COAGULATION ANALYZER?

The FDA product code for DESTINY MAX COAGULATION ANALYZER is JPA.

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Related Devices (Code: JPA)

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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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