Cleared Traditional

HISTOCHEMICAL AFB DEMONSTRATION

K771390 · Harleco · Pathology
Aug 1977
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K771390 is an FDA 510(k) clearance for the HISTOCHEMICAL AFB DEMONSTRATION, a Carbol Fuchsin (Class I — General Controls, product code ICL), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 26 days after receiving the submission on July 27, 1977. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K771390 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1977
Decision Date August 22, 1977
Days to Decision 26 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code ICL — Carbol Fuchsin
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850