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FDA 510(k)

FASTPACK TOTAL PSA METHOD VERIFICATION KIT

K-Number: K062957 · 2007-04-02

ApplicantQualigen, Inc.
Decision Date2007-04-02
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK TOTAL PSA METHOD VERIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2007-04-02 under 510(k) number K062957. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTPACK TOTAL PSA METHOD VERIFICATION KIT?

FASTPACK TOTAL PSA METHOD VERIFICATION KIT is a medical device that received FDA 510(k) clearance on 2007-04-02. The listed applicant is Qualigen, Inc.. The 510(k) number is K062957.

When did FASTPACK TOTAL PSA METHOD VERIFICATION KIT receive FDA 510(k) clearance?

FASTPACK TOTAL PSA METHOD VERIFICATION KIT received FDA 510(k) clearance on 2007-04-02, under 510(k) number K062957.

Who is the listed applicant for FASTPACK TOTAL PSA METHOD VERIFICATION KIT?

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 PSA METHOD VERIFICATION KIT?

The FDA product code for FASTPACK TOTAL PSA METHOD VERIFICATION KIT is JJX.

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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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