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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 AFB REAGENTS ON THE ACCESS 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 NumberS017
Date Received03/15/2012
Decision Date04/13/2012
Product Code LOK 
Advisory Committee Immunology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES; 2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS; 4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.
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