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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K952385
Device Name HEMA-TROL Q-CHECK
Applicant
Medical Specialties Intl., Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact W. KEVIN LIDDLE
Correspondent
Medical Specialties Intl., Inc.
3610 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact W. KEVIN LIDDLE
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
JPK  
Date Received05/22/1995
Decision Date 09/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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