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FDA 510(k)

RAPIDHCG PREGNANCY TEST

K-Number: K981770 · 1998-06-05

ApplicantRapid Diagnostics, Inc.
Decision Date1998-06-05
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAPIDHCG PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K981770. 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 RAPIDHCG PREGNANCY TEST?

RAPIDHCG PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Rapid Diagnostics, Inc.. The 510(k) number is K981770.

When did RAPIDHCG PREGNANCY TEST receive FDA 510(k) clearance?

RAPIDHCG PREGNANCY TEST received FDA 510(k) clearance on 1998-06-05, under 510(k) number K981770.

Who is the listed applicant for RAPIDHCG PREGNANCY TEST?

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

What is the FDA product code for RAPIDHCG PREGNANCY TEST?

The FDA product code for RAPIDHCG PREGNANCY TEST is JHI.

Related Clinical Trials

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Other records listing Rapid Diagnostics, 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.

K033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)K003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

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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