Cleared Traditional

17-HYDROXY TEST

K772426 · Hycel, Inc. · Chemistry
Jan 1978
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K772426 is an FDA 510(k) clearance for the 17-HYDROXY TEST, a Porter Silber Hydrazone, 17-hydroxycorticosteroids (Class I — General Controls, product code CDB), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978, 34 days after receiving the submission on December 27, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1385.

Submission Details

510(k) Number K772426 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1977
Decision Date January 30, 1978
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDB — Porter Silber Hydrazone, 17-hydroxycorticosteroids
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1385