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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K945913
Device Name IRISPEC URINE CHEMISTRY CONTROL PART A AND B
Applicant
International Remote Imaging Systems
9825 De Soto Ave.
Chartsworth,  CA  91311
Applicant Contact SANFORD WIDRAN
Correspondent
International Remote Imaging Systems
9825 De Soto Ave.
Chartsworth,  CA  91311
Correspondent Contact SANFORD WIDRAN
Regulation Number862.1660
Classification Product Code
JJW  
Date Received12/02/1994
Decision Date 04/05/1995
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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