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FDA 510(k)

CMV MICROASSAY

K-Number: K864420 · 1987-02-02

ApplicantDiamedix Corp.
Decision Date1987-02-02
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV MICROASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K864420. 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 MICROASSAY?

CMV MICROASSAY is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Diamedix Corp.. The 510(k) number is K864420.

When did CMV MICROASSAY receive FDA 510(k) clearance?

CMV MICROASSAY received FDA 510(k) clearance on 1987-02-02, under 510(k) number K864420.

Who is the listed applicant for CMV MICROASSAY?

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

What is the FDA product code for CMV MICROASSAY?

The FDA product code for CMV MICROASSAY is GQI.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

View all 68 devices →

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.K863488ENZYGNOST ANTI-CMV IGG TESTBehring 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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