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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 IMMUNOASSAY SYSTEMS
Generic NameKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
ApplicantBECKMAN COULTER, INC.
250 SOUTH KRAEMER BLVD M/S
W-110
BREA, CA 92822
PMA NumberP980041
Supplement NumberS013
Date Received09/27/2010
Decision Date07/01/2011
Product Code LOK 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS MADE TO THE ACCESS, SYNCHRON AND UNICEL FAMILIES OF INSTRUMENTATION PLATFORMS: 1) MODIFICATION OF THE OCCLUSION BRACKET ON THE ACCESS AND UNICEL INSTRUMENTS, B) REVISION OF THE UNICEL SYSTEM SOFTWARE, AND C) REDESIGN OF THE SAMPLE PROBE TUBE ASSEMBLY, AND D) NEW INFORMATION REGARDING POTENTIAL INTERFERENTS OF AFP MEASUREMENT DUE TO THE PRESENCE OF IMMUNOSUPPRESSANT DRUGS PRESCRIBED TO PREGNANT WOMEN.
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