Cleared Traditional

K050748 - ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
(FDA 510(k) Clearance)

K050748 · Scantibodies Laboratory, Inc. · Chemistry

May 2005

Decision

59d

Days

Class 2

Risk

K050748 is an FDA 510(k) clearance for the ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011, a Radioimmunoassay, Acth (Class II — Special Controls, product code CKG), submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on May 20, 2005, 59 days after receiving the submission on March 22, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1025.

Submission Details

510(k) Number	K050748 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2005
Decision Date	May 20, 2005
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement