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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer For Clinical Use
510(k) Number K831213
Device Name SPECIFIC GRAVITY INSTRUMENT
Applicant
Iris
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Iris
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2800
Classification Product Code
JRE  
Date Received04/14/1983
Decision Date 06/30/1983
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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