Interlab Ife Test Using G 26 Ver. 2.0 Instrument

FDA 510(k) K120169 · Grifols USA, LLC

Substantially Equivalent

510(k) numberK120169

Submission

Device name
Interlab Ife Test Using G 26 Ver. 2.0 Instrument
Applicant
Grifols USA, LLC
East Stroudsburg, PA, US
Received
January 19, 2012
Decision date
August 24, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

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Questions and answers

When was Interlab Ife Test Using G 26 Ver. 2.0 Instrument cleared by the FDA?

Interlab Ife Test Using G 26 Ver. 2.0 Instrument (K120169) received a 510(k) decision of Substantially Equivalent on August 24, 2012, 218 days after the submission was received.

What is the product code of K120169?

The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.