Cleared Traditional

RETIC-SET

K841848 · R&D Systems, Inc. · Hematology
May 1984
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K841848 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. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1984, 64 days after receiving the submission on March 28, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number K841848 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1984
Decision Date May 31, 1984
Days to Decision 64 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