Cleared Traditional

INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT

K120169 · Grifols USA, LLC · Immunology

Aug 2012

Decision

218d

Days

Class 2

Risk

About This 510(k) Submission

K120169 is an FDA 510(k) clearance for the INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Grifols USA, LLC (East Stroudsburg, US). The FDA issued a Cleared decision on August 24, 2012, 218 days after receiving the submission on January 19, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K120169 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2012
Decision Date	August 24, 2012
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF