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FDA 510(k)

CEDIA (R) VITAMIN B12/FOLATE ASSAY

K-Number: K904776 · 1990-11-20

ApplicantMicrogenics Corp.
Decision Date1990-11-20
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CEDIA (R) VITAMIN B12/FOLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1990-11-20 under 510(k) number K904776. 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 CEDIA (R) VITAMIN B12/FOLATE ASSAY?

CEDIA (R) VITAMIN B12/FOLATE ASSAY is a medical device that received FDA 510(k) clearance on 1990-11-20. The listed applicant is Microgenics Corp.. The 510(k) number is K904776.

When did CEDIA (R) VITAMIN B12/FOLATE ASSAY receive FDA 510(k) clearance?

CEDIA (R) VITAMIN B12/FOLATE ASSAY received FDA 510(k) clearance on 1990-11-20, under 510(k) number K904776.

Who is the listed applicant for CEDIA (R) VITAMIN B12/FOLATE ASSAY?

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

What is the FDA product code for CEDIA (R) VITAMIN B12/FOLATE ASSAY?

The FDA product code for CEDIA (R) VITAMIN B12/FOLATE ASSAY is CDD.

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Other records listing Microgenics Corp. as applicant

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K122766THERMO SCIENTIFIC QMS EVEROLIMUS ASSAYK123343THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSK123271ABBOTT PHENOBARBITAL ASSAYK110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PROK101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAYK101746THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

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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.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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