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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 the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-09-20 under 510(k) 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. The listed applicant is Diazyme Laboratories. The 510(k) number is K161721.

When did Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set?

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

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)

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.

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)Axis-Shield Diagnostics Limited

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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