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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Method, Catecholamines
510(k) Number K760920
Device Name CAT-A-KIT
Applicant
The Upjohn Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
The Upjohn Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1165
Classification Product Code
CHT  
Date Received10/28/1976
Decision Date 11/09/1976
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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