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FDA 510(k)

A/C ENZYMATIC VITAMIN B6 ASSAY

K-Number: K111260 · 2012-07-26

ApplicantAnticancer, Inc.
Decision Date2012-07-26
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A/C ENZYMATIC VITAMIN B6 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Anticancer, Inc.. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K111260. 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 A/C ENZYMATIC VITAMIN B6 ASSAY?

A/C ENZYMATIC VITAMIN B6 ASSAY is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Anticancer, Inc.. The 510(k) number is K111260.

When did A/C ENZYMATIC VITAMIN B6 ASSAY receive FDA 510(k) clearance?

A/C ENZYMATIC VITAMIN B6 ASSAY received FDA 510(k) clearance on 2012-07-26, under 510(k) number K111260.

Who is the listed applicant for A/C ENZYMATIC VITAMIN B6 ASSAY?

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

What is the FDA product code for A/C ENZYMATIC VITAMIN B6 ASSAY?

The FDA product code for A/C ENZYMATIC VITAMIN B6 ASSAY is CDD.

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Other records listing Anticancer, Inc. 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.

K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAYK030754A/C ENZYMATIC HOMOCYSTEINE ASSAY

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.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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