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FDA 510(k)

CMV-IHA

K-Number: K852494 · 1985-09-16

ApplicantHillcrest Biologicals
Decision Date1985-09-16
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CMV-IHA is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K852494. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMV-IHA?

CMV-IHA is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Hillcrest Biologicals. The 510(k) number is K852494.

When did CMV-IHA receive FDA 510(k) clearance?

CMV-IHA received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852494.

Who is the listed applicant for CMV-IHA?

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

What is the FDA product code for CMV-IHA?

The FDA product code for CMV-IHA is LJO.

Other records listing Hillcrest Biologicals 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.

K913617ARBOVIRUS IGG IFA TESTK913618ARBOVIRUS IGM IFA TESTK913906Q FEVER IGG IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

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Related Devices (Code: LJO)

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.

K203612Capture-CMVImmucor, Inc.K183571Capture-CMVImmucor, Inc.K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.K974456CMVGENInstrumentation Laboratory COK951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., 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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