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FDA 510(k)

VISTA B12 ASSAY

K-Number: K941235 · 1994-08-15

ApplicantSyva Co.
Decision Date1994-08-15
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISTA B12 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co.. It received FDA 510(k) clearance on 1994-08-15 under 510(k) number K941235. 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 VISTA B12 ASSAY?

VISTA B12 ASSAY is a medical device that received FDA 510(k) clearance on 1994-08-15. The listed applicant is Syva Co.. The 510(k) number is K941235.

When did VISTA B12 ASSAY receive FDA 510(k) clearance?

VISTA B12 ASSAY received FDA 510(k) clearance on 1994-08-15, under 510(k) number K941235.

Who is the listed applicant for VISTA B12 ASSAY?

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

What is the FDA product code for VISTA B12 ASSAY?

The FDA product code for VISTA B12 ASSAY is CDD.

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Other records listing Syva Co. 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.

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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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