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FDA 510(k)

HOLOTC RIA

K-Number: K030655 · 2004-01-29

ApplicantAxis-Shield Biochemicals, Asa
Decision Date2004-01-29
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOLOTC RIA is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Biochemicals, Asa. It received FDA 510(k) clearance on 2004-01-29 under 510(k) number K030655. 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 HOLOTC RIA?

HOLOTC RIA is a medical device that received FDA 510(k) clearance on 2004-01-29. The listed applicant is Axis-Shield Biochemicals, Asa. The 510(k) number is K030655.

When did HOLOTC RIA receive FDA 510(k) clearance?

HOLOTC RIA received FDA 510(k) clearance on 2004-01-29, under 510(k) number K030655.

Who is the listed applicant for HOLOTC RIA?

The FDA 510(k) record lists Axis-Shield Biochemicals, Asa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLOTC RIA?

The FDA product code for HOLOTC RIA is CDD.

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.

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Other records listing Axis-Shield Biochemicals, Asa 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.

K001651BIO-RAD %CDT TIA

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

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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