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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Sickle Cell
510(k) Number K791971
Device Name MONOJECT SICKLE CELL KIT
Applicant
Sherwood Medical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sherwood Medical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7825
Classification Product Code
GHM  
Date Received10/02/1979
Decision Date 11/05/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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