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CLIA record K080107 and corresponding 510(K) Premarket Notification information
Test System Name | Vitek 2 Antimicrobial Susceptibility Test (Ast) {Gram Negative Piperacillin/tazobactam; Automated} |
Document Number |
K080107 |
Analyte Name | Antimicrobial |
Analyte Specialty | Bacteriology |
Complexity | HIGH |
Effective Date | 03/12/2008 |
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510(k) Premarket Notification Database
Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
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510(k) Number | K080107 |
Device Name | VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM |
Applicant |
BIOMERIEUX, INC.
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595 anglum rd. |
hazelwood,
MO
63042 |
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Contact | nancy weaver |
Regulation Number | 866.1645 |
Classification Product Code |
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Date Received | 01/15/2008 |
Decision Date | 02/28/2008 |
Decision |
substantially equivalent - CLIA submission (CS) |
Classification Advisory Committee |
Microbiology
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Review Advisory Committee |
Microbiology
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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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