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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Cell Indices
510(k) Number K020469
Device Name CAL-CHEX CD PLUS
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 Number864.8150
Classification Product Code
KRX  
Subsequent Product Codes
KRY   KRZ   KSA  
Date Received02/12/2002
Decision Date 04/04/2002
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
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