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FDA 510(k)

FastPack IP Sex Hormone Binding Globulin Immunoassay

K-Number: K182521 · 2019-01-29

ApplicantQualigen, Inc.
Decision Date2019-01-29
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FastPack IP Sex Hormone Binding Globulin Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2019-01-29 under 510(k) number K182521. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FastPack IP Sex Hormone Binding Globulin Immunoassay?

FastPack IP Sex Hormone Binding Globulin Immunoassay is a medical device that received FDA 510(k) clearance on 2019-01-29. The listed applicant is Qualigen, Inc.. The 510(k) number is K182521.

When did FastPack IP Sex Hormone Binding Globulin Immunoassay receive FDA 510(k) clearance?

FastPack IP Sex Hormone Binding Globulin Immunoassay received FDA 510(k) clearance on 2019-01-29, under 510(k) number K182521.

Who is the listed applicant for FastPack IP Sex Hormone Binding Globulin Immunoassay?

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

What is the FDA product code for FastPack IP Sex Hormone Binding Globulin Immunoassay?

The FDA product code for FastPack IP Sex Hormone Binding Globulin Immunoassay is CDZ.

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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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