Cleared Traditional

HEMATOXYLIN STAIN SOLUTION

K822352 · Fisher Scientific Co., LLC · Pathology
Aug 1982
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K822352 is an FDA 510(k) clearance for the HEMATOXYLIN STAIN SOLUTION, a Hematoxylin (Class I — General Controls, product code HYJ), submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982, 10 days after receiving the submission on August 6, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K822352 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1982
Decision Date August 16, 1982
Days to Decision 10 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYJ — Hematoxylin
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850