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FDA 510(k)

BIOSIGN HCG-ONE STEP PREGNANCY TEST

K-Number: K901011 · 1990-05-04

ApplicantPrinceton Biomedix
Decision Date1990-05-04
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSIGN HCG-ONE STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Biomedix. It received FDA 510(k) clearance on 1990-05-04 under 510(k) number K901011. 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 BIOSIGN HCG-ONE STEP PREGNANCY TEST?

BIOSIGN HCG-ONE STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1990-05-04. The listed applicant is Princeton Biomedix. The 510(k) number is K901011.

When did BIOSIGN HCG-ONE STEP PREGNANCY TEST receive FDA 510(k) clearance?

BIOSIGN HCG-ONE STEP PREGNANCY TEST received FDA 510(k) clearance on 1990-05-04, under 510(k) number K901011.

Who is the listed applicant for BIOSIGN HCG-ONE STEP PREGNANCY TEST?

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

What is the FDA product code for BIOSIGN HCG-ONE STEP PREGNANCY TEST?

The FDA product code for BIOSIGN HCG-ONE STEP PREGNANCY TEST is JHI.

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Other records listing Princeton Biomedix 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.

K942052LIFESIGN MI MYOGLOBINK925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TESTK930185OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEPK925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TESTK926308LIFESIGN HCG - ONE STEP HOME PREGNANCY TESTK894705BIOSPOT HCG-RAPID PREGNANCY TEST

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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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