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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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access ck-mb on the access immunoassay analyzer, models 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. k994439 01/14/2000
access myoglobin on the access immunoassay analyzer, models 33310, 33315, 33319, 33316 BECKMAN COULTER, INC. k000196 02/18/2000
access thyroglobulin reagents on the access analyzer BECKMAN COULTER, INC. k002905 10/19/2000
accu-chek advantage meter ROCHE DIAGNOSTICS CORP. k000365 02/23/2000
accu-chek complete meter ROCHE DIAGNOSTICS CORP. k000364 02/23/2000
accuwarm emg heat lamp RJL ASSOCIATES, LLC. k001800 09/12/2000
acl 9000 system INSTRUMENTATION LABORATORY CO. k000053 03/15/2000
acme spine system - series 6000, 7000, monoaxial and polyaxial screw system ACME SPINE, LLC. k001044 11/03/2000
acryderm silver antimicrobial strands model a-020103 ACRYMED, INC. k002909 10/13/2000
acticoat foam dressing WESTAIM BIOMEDICAL, INC. k000051 04/05/2000

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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