Ot Igg Sorbent

FDA 510(k) K934324 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK934324

Submission

Device name
Ot Igg Sorbent
Applicant
Organon Teknika Corp.
Durham, NC, US
Received
September 3, 1993
Decision date
April 21, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DEW – Igg, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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K962202Quantex IggDEW · Traditional Instrumentation Laboratory CO09/26/1996SE

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Questions and answers

When was Ot Igg Sorbent cleared by the FDA?

Ot Igg Sorbent (K934324) received a 510(k) decision of Substantially Equivalent on April 21, 1994, 230 days after the submission was received.

What is the product code of K934324?

The FDA product code is DEW – Igg, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.