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FDA 510(k)

PROCLINIC ONE STEP PREGNANCY TEST

K-Number: K914253 · 1991-10-11

ApplicantVanguard Biomedical Corp.
Decision Date1991-10-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROCLINIC ONE STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Vanguard Biomedical Corp.. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K914253. 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 PROCLINIC ONE STEP PREGNANCY TEST?

PROCLINIC ONE STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Vanguard Biomedical Corp.. The 510(k) number is K914253.

When did PROCLINIC ONE STEP PREGNANCY TEST receive FDA 510(k) clearance?

PROCLINIC ONE STEP PREGNANCY TEST received FDA 510(k) clearance on 1991-10-11, under 510(k) number K914253.

Who is the listed applicant for PROCLINIC ONE STEP PREGNANCY TEST?

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

What is the FDA product code for PROCLINIC ONE STEP PREGNANCY TEST?

The FDA product code for PROCLINIC ONE STEP PREGNANCY TEST is JHI.

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Other records listing Vanguard Biomedical 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.

K960733MINISTICK PREGNANCY TESTK960233MINICLINIC OVULATION PREDICTORK930014PROCLINIC ONE-STEP DIPSTICK PREGNANCY TESTK914254HOMECLINIC ONE STEP PREGNANCY TESTK910351MINICLINIC OVULATION PREDICTION TESTK895560MODIFIED HOMECLINIC 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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