FDA 510(k)

Instant-View® hCG Combo II Cassette Test

K-번호: K262299 · 2026-09-22

결정일2026-09-22

제품 코드JHI

자문 위원회CH

결정Substantially Equivalent

기기 요약

Instant-View® hCG Combo II Cassette Test is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Scientific Designs, Inc.. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K262299. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Instant-View® hCG Combo II Cassette Test?

Instant-View® hCG Combo II Cassette Test is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Alfa Scientific Designs, Inc.. The 510(k) number is K262299.

When did Instant-View® hCG Combo II Cassette Test receive FDA 510(k) clearance?

Instant-View® hCG Combo II Cassette Test received FDA 510(k) clearance on 2026-09-22, under 510(k) number K262299.

Who is the listed applicant for Instant-View® hCG Combo II Cassette Test?

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

What is the FDA product code for Instant-View® hCG Combo II Cassette Test?

The FDA product code for Instant-View® hCG Combo II Cassette Test is JHI.

Alfa Scientific Designs, Inc.를 신청인으로 등재한 기타 기록

K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

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