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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name kit, test, pregnancy, hcg, over the counter
510(k) Number K863999
Device Name VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
Applicant
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
southfield,  MI  48075
Applicant Contact lee, ph.d.
Correspondent
LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
southfield,  MI  48075
Correspondent Contact lee, ph.d.
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/14/1986
Decision Date 01/09/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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