Cleared Traditional

VOLU-SOL NMB RETICULOCYTE STAIN

K792496 · Volu Sol Medical Industries · Hematology
Dec 1979
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K792496 is an FDA 510(k) clearance for the VOLU-SOL NMB RETICULOCYTE STAIN, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979, 27 days after receiving the submission on December 4, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K792496 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1979
Decision Date December 31, 1979
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQC — Stains, Hematology
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.1850