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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 K811806
Device Name QUICK-CHEM COLORIMETER
Applicant
The Dow Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Dow Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/25/1981
Decision Date 07/15/1981
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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