Cleared Traditional

SIGMA PERIODIC ACID-SCHIFF STAIN 395

K843752 · Sigma Chemical Co. · Hematology
Oct 1984
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K843752 is an FDA 510(k) clearance for the SIGMA PERIODIC ACID-SCHIFF STAIN 395, a Reagent, Schiff (Class I — General Controls, product code HZT), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on October 30, 1984, 35 days after receiving the submission on September 25, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K843752 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1984
Decision Date October 30, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code HZT — Reagent, Schiff
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850