Cleared Traditional

INSTANT HEMATOXYLIN

K873107 · Shandon, Inc. · Pathology
Aug 1987
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K873107 is an FDA 510(k) clearance for the INSTANT HEMATOXYLIN, a Hematoxylin Harris's (Class I — General Controls, product code HYK), submitted by Shandon, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on August 21, 1987, 14 days after receiving the submission on August 7, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K873107 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 1987
Decision Date August 21, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code HYK — Hematoxylin Harris's
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850