Cleared Traditional

K951013 - OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT
(FDA 510(k) Clearance)

K951013 · Olympus America, Inc. · Immunology

Apr 1995

Decision

42d

Days

Class 2

Risk

K951013 is an FDA 510(k) clearance for the OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT, a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFQ), submitted by Olympus America, Inc. (Lake Success, US). The FDA issued a Cleared decision on April 17, 1995, 42 days after receiving the submission on March 6, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K951013 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 1995
Decision Date	April 17, 1995
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement