AUDIT MICROCV PROCALCITONIN LINEARITY— 510(k) K101434

Clearance details

Applicant

Aalto Scientific, Ltd.

Product code

Code MJX

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2010-05-21

Decision date

2010-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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