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 | SENSITITRE |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 210 BUSINESS PARK DR. SUN PRAIRIE, WI 53590 |
PMA Number | N50531 |
Supplement Number | S004 |
Date Received | 01/30/1981 |
Decision Date | 04/14/1981 |
Reclassified Date
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09/13/2002 |
Product Code |
LON |
Advisory Committee |
Microbiology |
Expedited Review Granted? | No |
Combination Product | No |
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