Cleared Traditional

EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE

K880596 · Sigma Chemical Co. · Pathology
Mar 1988
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K880596 is an FDA 510(k) clearance for the EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE, a Eosin Y (Class I — General Controls, product code HYB), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on March 31, 1988, 49 days after receiving the submission on February 11, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K880596 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1988
Decision Date March 31, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYB — Eosin Y
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850