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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K871694
Device Name HYPERFORMANCE CONTROLS (HP-CONTROLS)
Applicant
Rapid Diagnostic Laboratories, Inc.
C/O Eastern Laboratories Ltd.
95 Seaview Blvd.
Port Washington,  NY  11050
Applicant Contact DHAR, PH.D.
Correspondent
Rapid Diagnostic Laboratories, Inc.
C/O Eastern Laboratories Ltd.
95 Seaview Blvd.
Port Washington,  NY  11050
Correspondent Contact DHAR, PH.D.
Regulation Number862.3280
Classification Product Code
DIF  
Date Received04/28/1987
Decision Date 07/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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