Cleared Traditional

K021032 - ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
(FDA 510(k) Clearance)

K021032 · Scantibodies Laboratory, Inc. · Chemistry

Jun 2002

Decision

66d

Days

Class 2

Risk

K021032 is an FDA 510(k) clearance for the ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100, a Radioimmunoassay, Acth (Class II — Special Controls, product code CKG), submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on June 3, 2002, 66 days after receiving the submission on March 29, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1025.

Submission Details

510(k) Number	K021032 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2002
Decision Date	June 03, 2002
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement