Cleared Traditional

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE

K934497 · R&D Systems, Inc. · Hematology
Dec 1993
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K934497 is an FDA 510(k) clearance for the CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE, a Control, Cell Counter, Normal And Abnormal (Class II — Special Controls, product code JCN), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 6, 1993, 83 days after receiving the submission on September 14, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K934497 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1993
Decision Date December 06, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JCN — Control, Cell Counter, Normal And Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625