FDA 510(k)

DHEA TEST SET

K-Number: K771793 · 1977-11-02

Decision Date1977-11-02

Product CodeCIY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DHEA TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Wien Laboratories, Inc.. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771793. The device is classified under product code CIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DHEA TEST SET?

DHEA TEST SET is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Wien Laboratories, Inc.. The 510(k) number is K771793.

When did DHEA TEST SET receive FDA 510(k) clearance?

DHEA TEST SET received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771793.

Who is the listed applicant for DHEA TEST SET?

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

What is the FDA product code for DHEA TEST SET?

The FDA product code for DHEA TEST SET is CIY.

Other records listing Wien Laboratories, Inc. 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.