Cleared Traditional

R&D RET-LINE KIT

K013898 · R&D Systems, Inc. · Hematology

Jan 2002

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K013898 is an FDA 510(k) clearance for the R&D RET-LINE KIT, 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 January 22, 2002, 60 days after receiving the submission on November 23, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K013898 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2001
Decision Date	January 22, 2002
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF