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FDA 510(k)

Colli-Pee•Dx Urine Collection Kit

K-Number: K254121 · 2026-06-10

ApplicantDNA Genotek, Inc.
Decision Date2026-06-10
Product CodeSIH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Colli-Pee•Dx Urine Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K254121. The device is classified under product code SIH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Colli-Pee•Dx Urine Collection Kit?

Colli-Pee•Dx Urine Collection Kit is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K254121.

When did Colli-Pee•Dx Urine Collection Kit receive FDA 510(k) clearance?

Colli-Pee•Dx Urine Collection Kit received FDA 510(k) clearance on 2026-06-10, under 510(k) number K254121.

Who is the listed applicant for Colli-Pee•Dx Urine Collection Kit?

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

What is the FDA product code for Colli-Pee•Dx Urine Collection Kit?

The FDA product code for Colli-Pee•Dx Urine Collection Kit is SIH.

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Other records listing DNA Genotek, 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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