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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K030596
Device Name IMMUNICON CELLSAVE PRESERVATIVE TUBE
Applicant
Immunicon Corp.
3401 Masons Mill Rd.
Suite 100
Huntingdon Valley,  PA  19006
Applicant Contact PETER SCOTT
Correspondent
Immunicon Corp.
3401 Masons Mill Rd.
Suite 100
Huntingdon Valley,  PA  19006
Correspondent Contact PETER SCOTT
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/25/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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