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FDA 510(k)

VENTREXYME EIA CONTROLS IMMUNOASSAY

K-Number: K841456 · 1984-05-21

ApplicantVxr, Inc.
Decision Date1984-05-21
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VENTREXYME EIA CONTROLS IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Vxr, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841456. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTREXYME EIA CONTROLS IMMUNOASSAY?

VENTREXYME EIA CONTROLS IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Vxr, Inc.. The 510(k) number is K841456.

When did VENTREXYME EIA CONTROLS IMMUNOASSAY receive FDA 510(k) clearance?

VENTREXYME EIA CONTROLS IMMUNOASSAY received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841456.

Who is the listed applicant for VENTREXYME EIA CONTROLS IMMUNOASSAY?

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 VENTREXYME EIA CONTROLS IMMUNOASSAY?

The FDA product code for VENTREXYME EIA CONTROLS IMMUNOASSAY is JIX.

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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 URINEK840473VENTREZYME T4 IMMUNOASSAY T4K833960VENTREX PREGNANCY TEST KIT ENZYMEK833989VENTREZYME THEOPHYLLINE IMMUNOASSAYK833878VENTREZYME DIGOXIN IMMUNOASSAY DIGOX

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.

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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