CARDIOIMMUNE XL CARDIAC MARKER CONTROL— 510(k) K061196

Clearance details

Applicant

Microgenics Corp.

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2006-04-28

Decision date

2006-05-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Fremont Blvd., CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061196.