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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 K992576
Device Name URINE CHEMISTRY CONTROL, LEVEL 1
Applicant
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744 -1832
Applicant Contact RUSTY SEWELL
Correspondent
Consolidated Technologies, Inc.
2170 Woodward St., Suite 100
Austin,  TX  78744 -1832
Correspondent Contact RUSTY SEWELL
Regulation Number862.1660
Classification Product Code
JJW  
Date Received08/02/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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