Progene Ige Bead Eia

FDA 510(k) K895294 · Progene Corp.

Substantially Equivalent

510(k) numberK895294

Submission

Device name
Progene Ige Bead Eia
Applicant
Progene Corp.
Overland Park, KS, US
Received
August 25, 1989
Decision date
September 21, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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More from Adiatec SA

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Questions and answers

When was Progene Ige Bead Eia cleared by the FDA?

Progene Ige Bead Eia (K895294) received a 510(k) decision of Substantially Equivalent on September 21, 1989, 27 days after the submission was received.

What is the product code of K895294?

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