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FDA 510(k)

COMPLETE D 25-OH VITAMIN D CONTROL

K-Number: K113177 · 2012-05-10

Decision Date2012-05-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COMPLETE D 25-OH VITAMIN D CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2012-05-10 under 510(k) number K113177. 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 COMPLETE D 25-OH VITAMIN D CONTROL?

COMPLETE D 25-OH VITAMIN D CONTROL is a medical device that received FDA 510(k) clearance on 2012-05-10. The listed applicant is Quantimetrix Corp.. The 510(k) number is K113177.

When did COMPLETE D 25-OH VITAMIN D CONTROL receive FDA 510(k) clearance?

COMPLETE D 25-OH VITAMIN D CONTROL received FDA 510(k) clearance on 2012-05-10, under 510(k) number K113177.

Who is the listed applicant for COMPLETE D 25-OH VITAMIN D CONTROL?

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

What is the FDA product code for COMPLETE D 25-OH VITAMIN D CONTROL?

The FDA product code for COMPLETE D 25-OH VITAMIN D CONTROL is JJX.

Related Clinical Trials

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.

Other records listing Quantimetrix Corp. as applicant

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.

View all 37 devices →

Related Devices (Code: JJX)

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.

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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