VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042— 510(k) K863999

Substantially Equivalent

Leeco Diagnostics, Inc.

FDA 510(k) clearance K863999 for VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042, Substantially Equivalent on 1987-01-09. Applicant: Leeco Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Leeco Diagnostics, Inc.
Product code
Code LCX
Device class
Class 2
Regulation
21 CFR 862.1155
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Southfield, MI, US
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