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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K021922
Device Name MODIFICATION TO PARA 5X
Applicant
Streck Laboratories, Inc.
7002 S 109th St.
La Vista,  NE  68128
Applicant Contact PAUL KITTELSON
Correspondent
Streck Laboratories, Inc.
7002 S 109th St.
La Vista,  NE  68128
Correspondent Contact PAUL KITTELSON
Regulation Number864.8625
Classification Product Code
JPK  
Date Received06/11/2002
Decision Date 06/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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