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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K872749
Device Name SPECTROPHOTOMETERS MODELS:ABC+,ABC,S 500, S 1000
Applicant
Secomam Co.
551 Main St.
Metuchen,  NJ  08840
Applicant Contact PATRICK TEULIE
Correspondent
Secomam Co.
551 Main St.
Metuchen,  NJ  08840
Correspondent Contact PATRICK TEULIE
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received07/13/1987
Decision Date 09/16/1987
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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