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FDA 510(k)

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5

K-Number: K100716 · 2011-06-23

ApplicantAalto Scientific, Ltd.
Decision Date2011-06-23
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 is the device name listed in this FDA 510(k) record. The listed applicant is Aalto Scientific, Ltd.. It received FDA 510(k) clearance on 2011-06-23 under 510(k) number K100716. 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 AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5?

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 is a medical device that received FDA 510(k) clearance on 2011-06-23. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K100716.

When did AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 receive FDA 510(k) clearance?

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 received FDA 510(k) clearance on 2011-06-23, under 510(k) number K100716.

Who is the listed applicant for AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5?

The FDA 510(k) record lists Aalto Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5?

The FDA product code for AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 is GGN.

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Related Devices (Code: GGN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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