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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 a medical device manufactured by Qualigen, Inc.. It received FDA 510(k) clearance on 2019-01-29 under approval 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. It is manufactured by Qualigen, Inc.. The 510(k) number is K182521.

When was FastPack IP Sex Hormone Binding Globulin Immunoassay approved by the FDA?

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

What company makes FastPack IP Sex Hormone Binding Globulin Immunoassay?

FastPack IP Sex Hormone Binding Globulin Immunoassay is manufactured by Qualigen, Inc..

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

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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