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FDA 510(k)

QUIX RAPID PREGNANCY STRIP TEST

K-Number: K954993 · 1995-12-13

ApplicantGuardian Scientific, Corp.
Decision Date1995-12-13
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUIX RAPID PREGNANCY STRIP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Scientific, Corp.. It received FDA 510(k) clearance on 1995-12-13 under 510(k) number K954993. 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 QUIX RAPID PREGNANCY STRIP TEST?

QUIX RAPID PREGNANCY STRIP TEST is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Guardian Scientific, Corp.. The 510(k) number is K954993.

When did QUIX RAPID PREGNANCY STRIP TEST receive FDA 510(k) clearance?

QUIX RAPID PREGNANCY STRIP TEST received FDA 510(k) clearance on 1995-12-13, under 510(k) number K954993.

Who is the listed applicant for QUIX RAPID PREGNANCY STRIP TEST?

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

What is the FDA product code for QUIX RAPID PREGNANCY STRIP TEST?

The FDA product code for QUIX RAPID PREGNANCY STRIP TEST is JHI.

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Other records listing Guardian Scientific, 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.

K972156QUIX RAPID E. COLI O157 STRIP TESTK954994TRUSTK954995QUIX RAPID CHOLERA STRIP 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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