LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT— 510(k) K850056

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K850056 for LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT, Substantially Equivalent on 1985-02-06. Applicant: Leeco Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant
Leeco Diagnostics, Inc.
Product code
Code JLS
Device class
Class 1
Regulation
21 CFR 862.1620
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Southfield, MI, US
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