Cleared Traditional

ADVIA RETIC PLUS

K010461 · R&D Systems, Inc. · Hematology

Apr 2001

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K010461 is an FDA 510(k) clearance for the ADVIA RETIC PLUS, 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 April 3, 2001, 46 days after receiving the submission on February 16, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K010461 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2001
Decision Date	April 03, 2001
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF