Cleared Abbreviated

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH

K060452 · Neo-Genesis · Chemistry

Mar 2007

Decision

385d

Days

Class 1

Risk

About This 510(k) Submission

K060452 is an FDA 510(k) clearance for the ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH, a Radioimmunoassay, 17-hydroxyprogesterone (Class I — General Controls, product code JLX), submitted by Neo-Genesis (Portland, US). The FDA issued a Cleared decision on March 13, 2007, 385 days after receiving the submission on February 21, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1395.

Submission Details

510(k) Number	K060452 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 2006
Decision Date	March 13, 2007
Days to Decision	385 days
Submission Type	Abbreviated
Review Panel	Chemistry (CH)
Summary	Summary PDF