Cleared Traditional

RETIC-SET

K843619 · R&D Systems, Inc. · Hematology
Oct 1984
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K843619 is an FDA 510(k) clearance for the RETIC-SET, a Stains, Hematology (Class I — General Controls, product code KQC), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 30, 1984, 46 days after receiving the submission on September 14, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K843619 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1984
Decision Date October 30, 1984
Days to Decision 46 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