MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)— 510(k) K093384

Clearance details

Applicant

Diamond Diagnostics, Inc.

Product code

Code JJY

Device class

Class 1

Regulation

21 CFR 862.1660

Advisory panel

Clinical Chemistry

Date received

2009-10-30

Decision date

2010-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Holliston, 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 K093384.