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FDA 510(k)

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

K-Number: K161721 · 2016-09-20

ApplicantDiazyme Laboratories
Decision Date2016-09-20
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2016-09-20 under approval number K161721. 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 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set?

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set is a medical device that received FDA 510(k) clearance on 2016-09-20. It is manufactured by Diazyme Laboratories. The 510(k) number is K161721.

When was Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set approved by the FDA?

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set received FDA 510(k) clearance on 2016-09-20, under approval number K161721.

What company makes Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set?

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set is manufactured by Diazyme Laboratories.

What is the FDA product code for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set?

The FDA product code for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set is CDD.

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Related Devices (Code: 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.

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