Cleared Traditional

CBC-SF

K010409 · R&D Systems, Inc. · Hematology
Mar 2001
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K010409 is an FDA 510(k) clearance for the CBC-SF, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 16, 2001, 32 days after receiving the submission on February 12, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K010409 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2001
Decision Date March 16, 2001
Days to Decision 32 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625