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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Hemoglobin, Abnormal
510(k) Number K820037
Device Name SICKLE-CHECK
Applicant
Diagnostic Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7415
Classification Product Code
JCM  
Date Received01/07/1982
Decision Date 02/04/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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