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FDA 510(k)

STA- COAG CONTROL (N+ABN) PLUS

K-Number: K120014 · 2013-03-14

ApplicantDiagnostica Stago, Inc.
Decision Date2013-03-14
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA- COAG CONTROL (N+ABN) PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K120014. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA- COAG CONTROL (N+ABN) PLUS?

STA- COAG CONTROL (N+ABN) PLUS is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K120014.

When did STA- COAG CONTROL (N+ABN) PLUS receive FDA 510(k) clearance?

STA- COAG CONTROL (N+ABN) PLUS received FDA 510(k) clearance on 2013-03-14, under 510(k) number K120014.

Who is the listed applicant for STA- COAG CONTROL (N+ABN) PLUS?

The FDA 510(k) record lists Diagnostica Stago, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA- COAG CONTROL (N+ABN) PLUS?

The FDA product code for STA- COAG CONTROL (N+ABN) PLUS is GGN.

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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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