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FDA 510(k)

ALFIS Vitamin D, ALFIS-3 Analyzer

K-Number: K221817 · 2023-09-22

ApplicantImmunostics Inc.,
Decision Date2023-09-22
Product CodeMRG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALFIS Vitamin D, ALFIS-3 Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Immunostics Inc.,. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K221817. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALFIS Vitamin D, ALFIS-3 Analyzer?

ALFIS Vitamin D, ALFIS-3 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Immunostics Inc.,. The 510(k) number is K221817.

When did ALFIS Vitamin D, ALFIS-3 Analyzer receive FDA 510(k) clearance?

ALFIS Vitamin D, ALFIS-3 Analyzer received FDA 510(k) clearance on 2023-09-22, under 510(k) number K221817.

Who is the listed applicant for ALFIS Vitamin D, ALFIS-3 Analyzer?

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

What is the FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer?

The FDA product code for ALFIS Vitamin D, ALFIS-3 Analyzer is MRG.

Other records listing Immunostics Inc., as applicant

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Related Devices (Code: MRG)

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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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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