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FDA 510(k)

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY

K-Number: K926422 · 1993-06-02

ApplicantSyva Co.
Decision Date1993-06-02
Product CodeGGJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) 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 1993-06-02 under 510(k) number K926422. The device is classified under product code GGJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY?

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY is a medical device that received FDA 510(k) clearance on 1993-06-02. The listed applicant is Syva Co.. The 510(k) number is K926422.

When did VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY receive FDA 510(k) clearance?

VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY received FDA 510(k) clearance on 1993-06-02, under 510(k) number K926422.

Who is the listed applicant for VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) 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(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY?

The FDA product code for VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY is GGJ.

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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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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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