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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Cell Counter, Normal And Abnormal
510(k) Number K993825
Device Name PARA TECH PLUS RETICS
Applicant
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Applicant Contact PAUL KITTELSON
Correspondent
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Correspondent Contact PAUL KITTELSON
Regulation Number864.8625
Classification Product Code
JCN  
Date Received11/12/1999
Decision Date 11/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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