Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | Abbott Laboratories 100 ABBOTT PARK ROAD DEPT 9VA AP6C-2 ABBOTT PARK, IL 60064-3500 |
PMA Number | N50525 |
Supplement Number | S021 |
Date Received | 01/10/1989 |
Decision Date | 03/10/1989 |
Withdrawal Date
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12/10/2007 |
Product Code |
LON |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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