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 | S015 |
Date Received | 10/27/1987 |
Decision Date | 01/11/1988 |
Withdrawal Date
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12/10/2007 |
Product Code |
LON |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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