| 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 | S083 |
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| Date Received | 07/09/1998 |
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| Decision Date | 09/15/1998 |
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| Product Code | |
| Docket Number | N |
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| Advisory Committee |
Microbiology |
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| Supplement Type | normal 180 day track |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the removal of a limitation for the testing of pseudomonas aeruginosa with the antibiotic cefepime. |
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