Cleared Traditional

PAPANICOLAOU STAIN SYS HT40

K840054 · Sigma Chemical Co. · Hematology
Feb 1984
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K840054 is an FDA 510(k) clearance for the PAPANICOLAOU STAIN SYS HT40, a Stain, Papanicolau (Class I — General Controls, product code HZJ), submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984, 42 days after receiving the submission on January 6, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K840054 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1984
Decision Date February 17, 1984
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code HZJ — Stain, Papanicolau
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850