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FDA 510(k)

VENTREX PREGNANCY TEST KIT ENZYME

K-Number: K833960 · 1984-02-03

ApplicantVxr, Inc.
Decision Date1984-02-03
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREX PREGNANCY TEST KIT ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Vxr, Inc.. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K833960. 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 VENTREX PREGNANCY TEST KIT ENZYME?

VENTREX PREGNANCY TEST KIT ENZYME is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Vxr, Inc.. The 510(k) number is K833960.

When did VENTREX PREGNANCY TEST KIT ENZYME receive FDA 510(k) clearance?

VENTREX PREGNANCY TEST KIT ENZYME received FDA 510(k) clearance on 1984-02-03, under 510(k) number K833960.

Who is the listed applicant for VENTREX PREGNANCY TEST KIT ENZYME?

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

What is the FDA product code for VENTREX PREGNANCY TEST KIT ENZYME?

The FDA product code for VENTREX PREGNANCY TEST KIT ENZYME is JHI.

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Other records listing Vxr, Inc. 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.

K853703VENTREZYME T3 IMMUNOASSAY T3K853748VENTRESCREEN HCG URINEK841456VENTREXYME EIA CONTROLS IMMUNOASSAYK840473VENTREZYME T4 IMMUNOASSAY T4K833989VENTREZYME THEOPHYLLINE IMMUNOASSAYK833878VENTREZYME DIGOXIN IMMUNOASSAY DIGOX

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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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