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FDA 510(k)

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

K-Number: K964574 · 1997-01-21

ApplicantAthena Medical Corp.
Decision Date1997-01-21
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Athena Medical Corp.. It received FDA 510(k) clearance on 1997-01-21 under 510(k) number K964574. 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 AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST?

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1997-01-21. The listed applicant is Athena Medical Corp.. The 510(k) number is K964574.

When did AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST receive FDA 510(k) clearance?

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST received FDA 510(k) clearance on 1997-01-21, under 510(k) number K964574.

Who is the listed applicant for AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST?

The FDA 510(k) record lists Athena Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST?

The FDA product code for AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST is JHI.

Related Clinical Trials

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.

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Other records listing Athena Medical Corp. 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.

K962888AFFIRM ONE-STEP HOME 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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