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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic/Fluorometric Method, Catecholamines
510(k) Number K855214
Device Name CAT-3 CATECHOLAMINE ASSAY KIT
Applicant
Whale Scientific, Inc.
4945 Monaco St.
Commerce City,  CO  80022
Applicant Contact BARBARA G GRIFFIN
Correspondent
Whale Scientific, Inc.
4945 Monaco St.
Commerce City,  CO  80022
Correspondent Contact BARBARA G GRIFFIN
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received12/30/1985
Decision Date 03/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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