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FDA 510(k)

CMV EARLY ANTIGEN TEST

K-Number: K942171 · 1994-06-30

ApplicantNeogenex
Decision Date1994-06-30
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV EARLY ANTIGEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Neogenex. It received FDA 510(k) clearance on 1994-06-30 under 510(k) number K942171. The device is classified under product code GQI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV EARLY ANTIGEN TEST?

CMV EARLY ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Neogenex. The 510(k) number is K942171.

When did CMV EARLY ANTIGEN TEST receive FDA 510(k) clearance?

CMV EARLY ANTIGEN TEST received FDA 510(k) clearance on 1994-06-30, under 510(k) number K942171.

Who is the listed applicant for CMV EARLY ANTIGEN TEST?

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

What is the FDA product code for CMV EARLY ANTIGEN TEST?

The FDA product code for CMV EARLY ANTIGEN TEST is GQI.

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Other records listing Neogenex 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.

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Related Devices (Code: GQI)

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.

K951800CMV IGG HUMAN SERUM CONTROLSPyramid Biological Corp.K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSPyramid Biological Corp.K883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.K863488ENZYGNOST ANTI-CMV IGG TESTBehring Diagnostics, Inc.K861123THE GOLDEN QUAD TEST (CMV)Microbiological Research Corp.

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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