Cleared Traditional

NEPHROLYTE

K831502 · Flaitron Laboratories, Inc. · Pathology
Jul 1983
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K831502 is an FDA 510(k) clearance for the NEPHROLYTE, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by Flaitron Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 68 days after receiving the submission on May 11, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K831502 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1983
Decision Date July 18, 1983
Days to Decision 68 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KFC — Methylene Blue, Tissue Stain
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850