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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 K980888
Device Name GLYCACOR
Applicant
Exocell, Inc.
3508 Market St., Suite 420
Philadelphia,  PA  19104
Applicant Contact MARGO P COHEN
Correspondent
Exocell, Inc.
3508 Market St., Suite 420
Philadelphia,  PA  19104
Correspondent Contact MARGO P COHEN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received03/09/1998
Decision Date 08/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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