Decision Date2019-10-02
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
LIAISON Vitamin B12 is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2019-10-02 under 510(k) number K192064. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LIAISON Vitamin B12?
LIAISON Vitamin B12 is a medical device that received FDA 510(k) clearance on 2019-10-02. The listed applicant is DiaSorin, Inc.. The 510(k) number is K192064.
When did LIAISON Vitamin B12 receive FDA 510(k) clearance?
LIAISON Vitamin B12 received FDA 510(k) clearance on 2019-10-02, under 510(k) number K192064.
Who is the listed applicant for LIAISON Vitamin B12?
The FDA 510(k) record lists DiaSorin, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LIAISON Vitamin B12?
The FDA product code for LIAISON Vitamin B12 is CDD.
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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.