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 | AUTOBAC MIC TEST SYSTEM |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. DURHAM, NC 27712 |
PMA Number | N50524 |
Supplement Number | S019 |
Date Received | 03/28/1984 |
Decision Date | 09/13/1984 |
Reclassified Date
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05/06/2003 |
Product Code |
LON |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
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