Cleared Traditional

R & D BODY FLUID CONTROL

K020229 · R&D Systems, Inc. · Hematology

Feb 2002

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K020229 is an FDA 510(k) clearance for the R & D BODY FLUID CONTROL, 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 February 6, 2002, 14 days after receiving the submission on January 23, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K020229 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2002
Decision Date	February 06, 2002
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF