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FDA 510(k)

SINGLE-STEP PREGNANCY, HCG TEST

K-Number: K922290 · 1992-07-09

ApplicantAmerican Medical Products, Inc.
Decision Date1992-07-09
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE-STEP PREGNANCY, HCG TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Products, Inc.. It received FDA 510(k) clearance on 1992-07-09 under 510(k) number K922290. 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 SINGLE-STEP PREGNANCY, HCG TEST?

SINGLE-STEP PREGNANCY, HCG TEST is a medical device that received FDA 510(k) clearance on 1992-07-09. The listed applicant is American Medical Products, Inc.. The 510(k) number is K922290.

When did SINGLE-STEP PREGNANCY, HCG TEST receive FDA 510(k) clearance?

SINGLE-STEP PREGNANCY, HCG TEST received FDA 510(k) clearance on 1992-07-09, under 510(k) number K922290.

Who is the listed applicant for SINGLE-STEP PREGNANCY, HCG TEST?

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

What is the FDA product code for SINGLE-STEP PREGNANCY, HCG TEST?

The FDA product code for SINGLE-STEP PREGNANCY, HCG TEST is JHI.

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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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