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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEM
Classification Namep2psa
ApplicantBECKMAN COULTER, INC.
PMA NumberP090026
Supplement NumberS001
Date Received10/25/2012
Decision Date11/19/2012
Product Code
OYA
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of information to the manufacturing procedures of the instrument (specifically, the instructions for application of the adhesive to the mixer pulley assembly and the implementation of a verification test to ensure the mixer pulley assemblies pass the torque specification. ).
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