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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 NumberS013
Date Received08/26/2014
Decision Date10/24/2014
Product Code
OYA[ Registered Establishments with OYA ]
Advisory Committee Immunology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the access substrate bottle and cap.
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