Ic Microassay

FDA 510(k) K864312 · Diamedix Corp.

Substantially Equivalent

510(k) numberK864312

Submission

Device name
Ic Microassay
Applicant
Diamedix Corp.
Miami, FL, US
Received
November 3, 1986
Decision date
January 9, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DAK – Complement C1q, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5240
Specialty
Immunology

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K860996Sanassay Ic TestDAK · Traditional Scientific Sales Intl., Inc.03/30/1987SE
K862649Cytotech Cic Enzyme ImmunoassayDAK · Traditional Cytotech, Inc.09/04/1986SE

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Questions and answers

When was Ic Microassay cleared by the FDA?

Ic Microassay (K864312) received a 510(k) decision of Substantially Equivalent on January 9, 1987, 67 days after the submission was received.

What is the product code of K864312?

The FDA product code is DAK – Complement C1q, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5240.