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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K943493
Device Name DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER
Applicant
Hamilton Co.
3371 Lenora Church Od
Snellville,  GA  30278
Applicant Contact TIMOTHY COWART
Correspondent
Hamilton Co.
3371 Lenora Church Od
Snellville,  GA  30278
Correspondent Contact TIMOTHY COWART
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
JJQ   JTC  
Date Received07/19/1994
Decision Date 01/30/1995
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
Recalls CDRH Recalls
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