| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | VITEK SYSTEMS "GENERAL SUSCEPTIBILITY CARD" |
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| Classification Name | susceptibility test cards, antimicrobial |
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| Generic Name | susceptibility test cards, antimicrobial |
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| Regulation Number | 866.1640 |
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| Applicant | BIOMERIEUX VITEK, INC. |
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| PMA Number | N50510 |
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| Supplement Number | S071 |
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| Date Received | 09/09/1996 |
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| Decision Date | 12/20/1996 |
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| Product Code | |
| Advisory Committee |
Microbiology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for meropenem to be included on the gram negative susceptibility card in three concentrations (equivalent to 2, 4, and 8ug/ml). |
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