Device Classification Name |
system, nucleic acid amplification test, dna, methicillin resistant staphylococcus aureus, direct specimen |
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510(k) Number | K112424 | |||
Device Name | VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) | |||
Applicant |
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Applicant Contact | mark del vecchio | |||
Correspondent |
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Correspodent Contact | mark del vecchio | |||
Regulation Number | 866.1640 | |||
Classification Product Code |
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Subsequent Product Code |
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Date Received | 08/23/2011 | |||
Decision Date | 12/16/2011 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Microbiology |
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510k Review Panel |
Microbiology |
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summary |
summary |
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FDA Review | Decision Summary | |||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |