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FDA 510(k)

ACCULINE PREGNANCY TEST

K-Number: K971122 · 1997-04-25

ApplicantGenix Biotek, Inc.
Decision Date1997-04-25
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCULINE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genix Biotek, Inc.. It received FDA 510(k) clearance on 1997-04-25 under 510(k) number K971122. 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 ACCULINE PREGNANCY TEST?

ACCULINE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1997-04-25. The listed applicant is Genix Biotek, Inc.. The 510(k) number is K971122.

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

ACCULINE PREGNANCY TEST received FDA 510(k) clearance on 1997-04-25, under 510(k) number K971122.

Who is the listed applicant for ACCULINE PREGNANCY TEST?

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

What is the FDA product code for ACCULINE PREGNANCY TEST?

The FDA product code for ACCULINE PREGNANCY TEST is JHI.

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Other records listing Genix Biotek, 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.

K964633ACCUPACK PREGNANCY TEST

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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