Cleared Traditional

SCHIFF REAGENT

K883217 · Surgipath Medical Industries, Inc. · Pathology
Aug 1988
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K883217 is an FDA 510(k) clearance for the SCHIFF REAGENT, a Reagent, Schiff (Class I — General Controls, product code HZT), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on August 5, 1988, 7 days after receiving the submission on July 29, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K883217 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 1988
Decision Date August 05, 1988
Days to Decision 7 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

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