Cleared Traditional

KETOSTEROID TEST, HYCEL-17

K782116 · Hycel, Inc. · Chemistry

Jan 1979

Decision

30d

Days

Class 1

Risk

About This 510(k) Submission

K782116 is an FDA 510(k) clearance for the KETOSTEROID TEST, HYCEL-17, a Zimmerman (spectrophotometric), 17-ketosteroids (Class I — General Controls, product code CCY), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979, 30 days after receiving the submission on December 27, 1978. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1430.

Submission Details

510(k) Number	K782116 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 1978
Decision Date	January 26, 1979
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—