Ebv-Ea Ifa Kit

FDA 510(k) K895652 · Organon Teknika Treyburn

Substantially Equivalent

510(k) numberK895652

Submission

Device name
Ebv-Ea Ifa Kit
Applicant
Organon Teknika Treyburn
Durham, NC, US
Received
September 20, 1989
Decision date
December 18, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LSE – Epstein-Barr Virus, Other
Device class
Class I (low risk)
Regulation
21 CFR 866.3235
Specialty
Microbiology

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K091260Seraquest Ebv Ea-D Igg TestLSE · Traditional Quest Intl., Inc.06/08/2009SE
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K062213Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional Bio-Rad Laboratories, Inc.12/08/2006SE
K062211Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional Bio-Rad Laboratories, Inc.12/08/2006SE
K060204Liaison Ea IggLSE · Traditional DiaSorin, Inc.10/18/2006SE
K033915Modification to Seraquest Eb Vca IggLSE · Special Quest Intl., Inc.01/16/2004SE
K030863Ebv VCA-P18 Igg ElisaLSE · Traditional Panbio Limited06/27/2003SE

Questions and answers

When was Ebv-Ea Ifa Kit cleared by the FDA?

Ebv-Ea Ifa Kit (K895652) received a 510(k) decision of Substantially Equivalent on December 18, 1989, 89 days after the submission was received.

What is the product code of K895652?

The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.