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CLIA record K061382 and corresponding 510(K) Premarket Notification information
Test System Name | Beckman Coulter UniCel DxI 600 Access Immunoassay System {ACCESS TPO Antibody Reagents} |
Document Number |
K061382 |
Analyte Name | Anti-Thyroid Peroxidase (TPO) Antibodies |
Analyte Specialty | General Immunology |
Complexity | MODERATE |
Effective Date | 06/25/2007 |
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510(k) Premarket Notification Database
Device Classification Name |
system, test, thyroid autoantibody
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510(k) Number | K061382 |
Device Name | ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 |
Applicant |
BECKMAN COULTER, INC.
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1000 lake hazeltine dr. |
chaska,
MN
55318 108 |
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Contact | valynda l machen |
Regulation Number | 866.5870 |
Classification Product Code |
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Subsequent Product Code |
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Date Received | 05/18/2006 |
Decision Date | 07/06/2006 |
Decision |
substantially equivalent - CLIA submission (CS) |
Classification Advisory Committee |
Immunology
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Review Advisory Committee |
Immunology
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Statement/Summary/Purged Status |
Summary only
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summary |
summary
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FDA Review |
Decision Summary
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Type |
Traditional
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Reviewed by Third Party |
No
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Expedited Review |
No
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