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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, magnesium
510(k) Number K851514
Device Name ULTRA-VIOLET GLUCOSE REAGENT
Applicant
BIO-ANALYTICS LABORATORIES, INC.
ONE BIO-ANALYTICS PLACE
BOX 333
PALM CITY,  FL  33490
Applicant Contact ROY
Correspondent
BIO-ANALYTICS LABORATORIES, INC.
ONE BIO-ANALYTICS PLACE
BOX 333
PALM CITY,  FL  33490
Correspondent Contact ROY
Regulation Number862.1495
Classification Product Code
CFA  
Date Received04/15/1985
Decision Date 05/20/1985
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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