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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Mixture
510(k) Number K875216
Device Name HIGH PERFORMANCE CALIBRATORS
Applicant
Rapid Diagnostic Laboratories, Inc.
C/O Eastern Laboratories Ltd.
95 Seaview Blvd.
Port Washington,  NY  11050
Applicant Contact AMIYA DHAR
Correspondent
Rapid Diagnostic Laboratories, Inc.
C/O Eastern Laboratories Ltd.
95 Seaview Blvd.
Port Washington,  NY  11050
Correspondent Contact AMIYA DHAR
Regulation Number862.3200
Classification Product Code
DKB  
Date Received12/22/1987
Decision Date 06/22/1988
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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