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FDA 510(k)

MINI STRIP/SERUM HCG

K-Number: K963132 · 1996-11-18

ApplicantInternational Newtech Development, Inc.
Decision Date1996-11-18
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MINI STRIP/SERUM 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 1996-11-18 under 510(k) number K963132. 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 MINI STRIP/SERUM HCG?

MINI STRIP/SERUM HCG is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is International Newtech Development, Inc.. The 510(k) number is K963132.

When did MINI STRIP/SERUM HCG receive FDA 510(k) clearance?

MINI STRIP/SERUM HCG received FDA 510(k) clearance on 1996-11-18, under 510(k) number K963132.

Who is the listed applicant for MINI STRIP/SERUM 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 MINI STRIP/SERUM HCG?

The FDA product code for MINI STRIP/SERUM HCG 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)K974060MINISTRIP/ SERUM AND URINE COMBO HCG TESTK974059ONE STEP MIDSTREAM HCG PREGNANCY TESTK974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCGK970176HCG CONTROLSK963133PS-UNIT CASSETTE/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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