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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 SYSTEMS
Classification Namep2psa
Generic Namehybritech p2psa reagents on the access immunoassay systems
ApplicantBECKMAN COULTER, INC.
PMA NumberP090026
Supplement NumberS015
Date Received05/07/2015
Decision Date06/23/2015
Product Code
OYA[ Registered Establishments with OYA ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to align with globally harmonized system of classification of chemicals (ghs) which provides a consistent hazard classification system that is recognized globally.
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