Biotest Anti-Ebv Recombinant, Ea Igm

FDA 510(k) K983842 · Biotest Diagnostics Corp.

Substantially Equivalent

510(k) numberK983842

Submission

Device name
Biotest Anti-Ebv Recombinant, Ea Igm
Applicant
Biotest Diagnostics Corp.
Denville, NJ, US
Received
October 30, 1998
Decision date
June 9, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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More from Panbio Limited

510(k)DeviceDecision
K991650CMV Brite Turbo KitLIN · Special 07/12/1999SE
K983841Biotest Anti-Ebv Recombinant, Ebna IggLSE · Traditional 06/09/1999SE
K983839Biotest Anti-Ebv RecombinantLSE · Traditional 06/09/1999SE
K951550CMV Brite Antigenemia Test KitLIN · Traditional 01/30/1996SE

Questions and answers

When was Biotest Anti-Ebv Recombinant, Ea Igm cleared by the FDA?

Biotest Anti-Ebv Recombinant, Ea Igm (K983842) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 222 days after the submission was received.

What is the product code of K983842?

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