CD-CAL PLUS CALIBRATOR— 510(k) K003991

Clearance details

Applicant

R&D Systems, Inc.

Product code

Code KRX

Device class

Class 2

Regulation

21 CFR 864.8150

Advisory panel

Hematology

Date received

2000-12-26

Decision date

2001-01-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Minneapolis, MN, US

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