Cleared Special

CD-CAL PLUS CALIBRATOR

K003991 · R&D Systems, Inc. · Hematology

Jan 2001

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K003991 is an FDA 510(k) clearance for the CD-CAL PLUS CALIBRATOR, a Calibrator For Cell Indices (Class II — Special Controls, product code KRX), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 16, 2001, 21 days after receiving the submission on December 26, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8150.

Submission Details

510(k) Number	K003991 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2000
Decision Date	January 16, 2001
Days to Decision	21 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Summary PDF