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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 K861897
Device Name UNISKAN II
Applicant
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Applicant Contact FRANK GREGORIO
Correspondent
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Correspondent Contact FRANK GREGORIO
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received05/16/1986
Decision Date 07/01/1986
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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