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FDA 510(k)

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

K-Number: K021972 · 2002-08-21

ApplicantQualigen, Inc.
Decision Date2002-08-21
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK TOTAL TESTOSTERONE 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 2002-08-21 under 510(k) number K021972. 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 TOTAL TESTOSTERONE IMMUNOASSAY?

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2002-08-21. The listed applicant is Qualigen, Inc.. The 510(k) number is K021972.

When did FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY receive FDA 510(k) clearance?

FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY received FDA 510(k) clearance on 2002-08-21, under 510(k) number K021972.

Who is the listed applicant for FASTPACK TOTAL TESTOSTERONE 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 TOTAL TESTOSTERONE IMMUNOASSAY?

The FDA product code for FASTPACK TOTAL TESTOSTERONE 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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