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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K781851
Device Name HEMOGLOBIN, TESTING SYSTEM
Applicant
Isolab, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Isolab, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/03/1978
Decision Date 11/07/1978
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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