CORTISOL LIA— 510(k) K010790

Substantially Equivalent

Kmi Diagnostics, Inc.

FDA 510(k) clearance K010790 for CORTISOL LIA, Substantially Equivalent on 2002-01-29. Applicant: Kmi Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Kmi Diagnostics, Inc.
Product code
Code CGR
Device class
Class 2
Regulation
21 CFR 862.1205
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
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