LEECO TESTOSTERONE DIAGNOSTIC KIT— 510(k) K830512

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K830512 for LEECO TESTOSTERONE DIAGNOSTIC KIT, Substantially Equivalent on 1983-04-05. Applicant: Leeco Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant
Leeco Diagnostics, Inc.
Product code
Code CDZ
Device class
Class 1
Regulation
21 CFR 862.1680
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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