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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 K852986
Device Name GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN
Applicant
Clinical Technology Corp.
50c Rocky Pt. Rd.
P.O. Box 1723
Rocky Point,  NY  11778
Applicant Contact PAUL C REITER
Correspondent
Clinical Technology Corp.
50c Rocky Pt. Rd.
P.O. Box 1723
Rocky Point,  NY  11778
Correspondent Contact PAUL C REITER
Regulation Number864.7470
Classification Product Code
LCP  
Date Received07/15/1985
Decision Date 08/19/1985
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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