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FDA 510(k)

CETUS CMV IHA

K-Number: K822965 · 1983-02-15

ApplicantCetus Corp.
Decision Date1983-02-15
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CETUS CMV IHA is the device name listed in this FDA 510(k) record. The listed applicant is Cetus Corp.. It received FDA 510(k) clearance on 1983-02-15 under 510(k) number K822965. 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 CETUS CMV IHA?

CETUS CMV IHA is a medical device that received FDA 510(k) clearance on 1983-02-15. The listed applicant is Cetus Corp.. The 510(k) number is K822965.

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

CETUS CMV IHA received FDA 510(k) clearance on 1983-02-15, under 510(k) number K822965.

Who is the listed applicant for CETUS CMV IHA?

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

What is the FDA product code for CETUS CMV IHA?

The FDA product code for CETUS CMV IHA is LJO.

Related Clinical Trials

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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Other records listing Cetus 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.

K861580PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEMK844968EPICHROME PAP

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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