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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCELLFREE(R) INTERLEUKIN-2 RECEPTOR* BEAD ASSAT KIT
Generic NameASSAY, INTERLEUKIN
ApplicantPierce Biotechnology, Inc.
3747 N. Meridian Rd.
P.O. Box 117
Rockford, IL 60115
PMA NumberP880040
Supplement NumberS003
Date Received03/24/1995
Decision Date08/07/1996
Withdrawal Date08/04/2011
Product Code MAN 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN ADDRESS OF THE MANUFACTURING SITE AND UPDATES AND REVISIONS IN STANDARD OPERATING PROCEDURES AND MANUFACTURING INFORMATION
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