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FDA 510(k)

MINISTRIP/ SERUM AND URINE COMBO HCG TEST

K-Number: K974060 · 1998-04-09

ApplicantInternational Newtech Development, Inc.
Decision Date1998-04-09
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MINISTRIP/ SERUM AND URINE COMBO HCG TEST 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 1998-04-09 under 510(k) number K974060. 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 MINISTRIP/ SERUM AND URINE COMBO HCG TEST?

MINISTRIP/ SERUM AND URINE COMBO HCG TEST is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K974060.

When did MINISTRIP/ SERUM AND URINE COMBO HCG TEST receive FDA 510(k) clearance?

MINISTRIP/ SERUM AND URINE COMBO HCG TEST received FDA 510(k) clearance on 1998-04-09, under 510(k) number K974060.

Who is the listed applicant for MINISTRIP/ SERUM AND URINE COMBO HCG TEST?

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 MINISTRIP/ SERUM AND URINE COMBO HCG TEST?

The FDA product code for MINISTRIP/ SERUM AND URINE COMBO HCG TEST is JHI.

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Other records listing International Newtech Development, 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.

K993850URINALYSIS REAGENT STRIPS (10 PARAMETERS)K974059ONE STEP MIDSTREAM HCG PREGNANCY TESTK974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCGK970176HCG CONTROLSK963133PS-UNIT CASSETTE/SERUM HCGK963132MINI STRIP/SERUM HCG

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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.

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

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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