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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 K852295
Device Name UROL-GUANT
Applicant
Dimension Diagnostics
P.O. Box 675
3080 N. Hwy. 94
St. Charles,  MO  63301
Applicant Contact CLYDE E HAM
Correspondent
Dimension Diagnostics
P.O. Box 675
3080 N. Hwy. 94
St. Charles,  MO  63301
Correspondent Contact CLYDE E HAM
Regulation Number862.1660
Classification Product Code
JJW  
Date Received05/29/1985
Decision Date 07/22/1985
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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