Cleared Traditional

FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT

K002638 · Future Diagnostics B.V. · Chemistry

Jan 2001

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K002638 is an FDA 510(k) clearance for the FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT, a Radioimmunoassay, Acth (Class II — Special Controls, product code CKG), submitted by Future Diagnostics B.V. (San Diego, US). The FDA issued a Cleared decision on January 17, 2001, 146 days after receiving the submission on August 24, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1025.

Submission Details

510(k) Number	K002638 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2000
Decision Date	January 17, 2001
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement