LEECO P.A.P. - QUANT DIAGNOSTIC KIT— 510(k) K810232

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K810232 for LEECO P.A.P. - QUANT DIAGNOSTIC KIT, Substantially Equivalent on 1981-02-10. Applicant: Leeco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Leeco Diagnostics, Inc.
Product code
Code JFH
Device class
Class 2
Regulation
21 CFR 862.1020
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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