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FDA 510(k)

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

K-Number: K100715 · 2010-12-23

ApplicantAalto Scientific, Ltd.
Decision Date2010-12-23
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-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 2010-12-23 under 510(k) number K100715. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5?

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 is a medical device that received FDA 510(k) clearance on 2010-12-23. The listed applicant is Aalto Scientific, Ltd.. The 510(k) number is K100715.

When did AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 receive FDA 510(k) clearance?

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 received FDA 510(k) clearance on 2010-12-23, under 510(k) number K100715.

Who is the listed applicant for AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-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 HOMOCYSTEINE LINEARITY SET, MODEL 704M-5?

The FDA product code for AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 is JJX.

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Related Devices (Code: JJX)

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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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