Cleared Traditional

K761271 - URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
(FDA 510(k) Clearance)

K761271 · Eppendorf-Brinkmann, Inc. · Chemistry
Feb 1977
Decision
56d
Days
Class 1
Risk

K761271 is an FDA 510(k) clearance for the URIN. L7-OH CORTICOSTEROID T(NON HYDRO), a Porter Silber Hydrazone, 17-hydroxycorticosteroids (Class I — General Controls, product code CDB), submitted by Eppendorf-Brinkmann, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 14, 1977, 56 days after receiving the submission on December 20, 1976. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1385.

Submission Details

510(k) Number K761271 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1976
Decision Date February 14, 1977
Days to Decision 56 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