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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K970824
Device Name MDX 2000, DIGITAL ANALYZER
Applicant
Shotwell & Carr, Inc.
3003 Lbj Freeway, Suite 100
Dallas,  TX  75234 -7755
Applicant Contact BERT HUDSON
Correspondent
Shotwell & Carr, Inc.
3003 Lbj Freeway, Suite 100
Dallas,  TX  75234 -7755
Correspondent Contact BERT HUDSON
Regulation Number864.5260
Classification Product Code
JOY  
Date Received03/06/1997
Decision Date 05/30/1997
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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