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 | MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS |
Generic Name | SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION |
Regulation Number | 866.1645 |
Applicant | DADE INTL., INC. 1584 ENTERPRISE BLVD. WEST SACRAMENTO,, CA 95691 |
PMA Number | P870049 |
Supplement Number | S025 |
Date Received | 09/28/1995 |
Decision Date | 05/03/1996 |
Reclassified Date
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05/06/2003 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR EXPANDED GENTAMICIN DILUTIONS AT CONCENTRATIONS OF 0.12-4, 6, AND 8UG/ML, THE REMOVAL OF THE LIMITATION FOR THE TESTING OF SALMONELLA/SHIGELLA WITH GENTAMICIN, AND ADDITIONAL LIMITATIONS FOR THE TESTING OF ACINETOBACTER BAUMANII AND STENOTROPHOMONAS MALTOPHILIA WITH GENTAMICIN |
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