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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.
 
DeviceACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameP2psa
ApplicantBECKMAN COULTER, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318
PMA NumberP090026
Supplement NumberS012
Date Received08/25/2014
Decision Date12/23/2014
Product Code OYA 
Advisory Committee Immunology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE CURRENT REAGENT REAL-TIME STABILITY TEST METHOD FOR ACCESS REAGENT PACKS, CALIBRATORS AND SAMPLES DILUENTS TO ENHANCE THE SAFETY AND RELIABILITY OF THE DEVICES PER 21 CFR 814.39(D)(2).
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