Cleared Traditional

HISTOCHEMICAL PAS REACTION SET

K760031 · Harleco · Hematology
Jul 1976
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K760031 is an FDA 510(k) clearance for the HISTOCHEMICAL PAS REACTION SET, a Reagent, Schiff (Class I — General Controls, product code HZT), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 36 days after receiving the submission on June 14, 1976. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K760031 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 1976
Decision Date July 20, 1976
Days to Decision 36 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