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FDA 510(k)

EBV-EA IFA KIT

K-Number: K895652 · 1989-12-18

ApplicantOrganon Teknika Treyburn
Decision Date1989-12-18
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-EA IFA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Treyburn. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K895652. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV-EA IFA KIT?

EBV-EA IFA KIT is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Organon Teknika Treyburn. The 510(k) number is K895652.

When did EBV-EA IFA KIT receive FDA 510(k) clearance?

EBV-EA IFA KIT received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895652.

Who is the listed applicant for EBV-EA IFA KIT?

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

What is the FDA product code for EBV-EA IFA KIT?

The FDA product code for EBV-EA IFA KIT is LSE.

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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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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