Cleared Traditional

BOUINS SOLUTION

K833515 · Sigma Chemical Co. · Pathology
Nov 1983
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K833515 is an FDA 510(k) clearance for the BOUINS SOLUTION, a Fluid, Bouin's (Class I — General Controls, product code IGN), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983, 34 days after receiving the submission on October 11, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K833515 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 1983
Decision Date November 14, 1983
Days to Decision 34 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGN — Fluid, Bouin's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010