EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL— 510(k) K120497

Clearance details

Applicant

Medica Corp.

Product code

Code LCP

Device class

Class 2

Regulation

21 CFR 864.7470

Advisory panel

Hematology

Date received

2012-02-21

Decision date

2012-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120497.