FDA 510(k)

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG

K-Number: K974009 · 1998-03-13

ApplicantInternational Newtech Development, Inc.

Decision Date1998-03-13

Product CodeJHI

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG is the device name listed in this FDA 510(k) record. The listed applicant is International Newtech Development, Inc.. It received FDA 510(k) clearance on 1998-03-13 under 510(k) number K974009. 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 PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG?

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K974009.

When did PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG receive FDA 510(k) clearance?

PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG received FDA 510(k) clearance on 1998-03-13, under 510(k) number K974009.

Who is the listed applicant for PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG?

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

What is the FDA product code for PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG?

The FDA product code for PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG is JHI.

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Other records listing International Newtech Development, Inc. as applicant

K993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)K974060MINISTRIP/ SERUM AND URINE COMBO HCG TEST K974059ONE STEP MIDSTREAM HCG PREGNANCY TEST K970176HCG CONTROLS K963133PS-UNIT CASSETTE/SERUM HCG K963132MINI STRIP/SERUM HCG

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Related Devices (Code: JHI)

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.