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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uranyl acetate/zinc acetate, sodium
510(k) Number K902572
Device Name SODIUM REAGENT SET
Applicant
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Applicant Contact CHEN, PH.D
Correspondent
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Correspondent Contact CHEN, PH.D
Regulation Number862.1665
Classification Product Code
CEI  
Date Received06/11/1990
Decision Date 07/10/1990
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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