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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 FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic NameTest, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
ApplicantBeckman Coulter, Inc.
250 S. Kraemer Blvd. M/S
W-110
Brea, CA 92822
PMA NumberP970038
Supplement NumberS013
Date Received01/10/2011
Decision Date02/07/2011
Product Code MTG 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD THE FOLLOWING NEW WARNING LABEL TO ALL ACCESS DXI SYSTEMS. ¿WARNING¿ ERRONEOUS RESULTS CAN OCCUR IF REAGENT PACKS ARE NOT LOADED PROPERLY. 1) NEVER TRANSFER A PARTIAL REAGENT PACK THAT WAS USED ON A DIFFERENT SYSTEM. 2) ALWAYS LOAD A REAGENT PACK BEFORE SCANNING THE BAR CODE (ACCESS/ACCESS 2 ONLY). FOR SPECIFIC INSTRUCTIONS, CONSULT THE SYSTEM DOCUMENTATION.
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