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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 K890534
Device Name MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
Applicant
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Applicant Contact B BREUER,PHD
Correspondent
Fisher Scientific Co., LLC
526 Rte. 303
Orangeburg,  NY  10962
Correspondent Contact B BREUER,PHD
Regulation Number862.1660
Classification Product Code
JJW  
Date Received01/26/1989
Decision Date 03/08/1989
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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