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FDA 510(k)

ENZYGNOST ANTI-CMV IGG TEST

K-Number: K863488 · 1987-07-20

ApplicantBehring Diagnostics, Inc.
Decision Date1987-07-20
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST ANTI-CMV IGG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-07-20 under 510(k) number K863488. 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 ENZYGNOST ANTI-CMV IGG TEST?

ENZYGNOST ANTI-CMV IGG TEST is a medical device that received FDA 510(k) clearance on 1987-07-20. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K863488.

When did ENZYGNOST ANTI-CMV IGG TEST receive FDA 510(k) clearance?

ENZYGNOST ANTI-CMV IGG TEST received FDA 510(k) clearance on 1987-07-20, under 510(k) number K863488.

Who is the listed applicant for ENZYGNOST ANTI-CMV IGG TEST?

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

What is the FDA product code for ENZYGNOST ANTI-CMV IGG TEST?

The FDA product code for ENZYGNOST ANTI-CMV IGG TEST is GQI.

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Other records listing Behring Diagnostics, Inc. as applicant

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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.K942171CMV EARLY ANTIGEN TESTNeogenexK883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.K864420CMV MICROASSAYDiamedix 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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