Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | FLOW MIC SYSTEM |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. MCLEAN, VA 22102 |
PMA Number | N50538 |
Date Received | 09/14/1979 |
Decision Date | 07/15/1980 |
Reclassified Date
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05/06/2003 |
Product Code |
LON |
Notice Date | 11/20/1980 |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
Supplements: |
S001 |
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