Cleared Traditional

TUBE, STAIN, RETICULOCYTE, LARC

K770792 · Corning Medical & Scientific · Hematology
Jul 1977
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K770792 is an FDA 510(k) clearance for the TUBE, STAIN, RETICULOCYTE, LARC, a Methylene Blue, Tissue Stain (Class I — General Controls, product code KFC), submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on July 5, 1977, 64 days after receiving the submission on May 2, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K770792 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1977
Decision Date July 05, 1977
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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