FDA 510(k)

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K-번호: K254121 · 2026-06-10

결정일2026-06-10

제품 코드SIH

자문 위원회미 (Original text: MI)

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기기 요약

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.

자주 묻는 질문

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.

DNA Genotek, Inc.를 신청인으로 등재한 기타 기록

K212745ORAcollect®•Dx K192920오라젠®•Dx K152556오라젠 Dx K152464ORAcollect.Dx

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기기 요약

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관련 임상시험

DNA Genotek, Inc.를 신청인으로 등재한 기타 기록

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