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FDA 510(k)

Instant-View® hCG Combo II Cassette Test

K-Number: K262299 · 2026-09-22

ApplicantAlfa Scientific Designs, Inc.
Decision Date2026-09-22
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Alfa Scientific Designs, 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.

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 TestK152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

Related Devices (Code: JHI)

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.

K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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