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FDA 510(k)

QUICKVUE ONE-STEP HCG-URINE

K-Number: K972742 · 1997-08-29

ApplicantQuidel Corp.
Decision Date1997-08-29
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICKVUE ONE-STEP HCG-URINE is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corp.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972742. 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 QUICKVUE ONE-STEP HCG-URINE?

QUICKVUE ONE-STEP HCG-URINE is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Quidel Corp.. The 510(k) number is K972742.

When did QUICKVUE ONE-STEP HCG-URINE receive FDA 510(k) clearance?

QUICKVUE ONE-STEP HCG-URINE received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972742.

Who is the listed applicant for QUICKVUE ONE-STEP HCG-URINE?

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

What is the FDA product code for QUICKVUE ONE-STEP HCG-URINE?

The FDA product code for QUICKVUE ONE-STEP HCG-URINE is JHI.

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Other records listing Quidel Corp. as applicant

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K131813QUIDEL MOLECULAR RSV + HMPV ASSAYK131728QUIDEL MOLECULAR INFLUENZA A + B ASSAYK130398SOFIA(R) RSV FIAK131166SOFIA(R) HCG FIAK131606SOFIA INFLUENZA A+B FIAK131619QUICKVUE INFLUENZA A+B

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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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