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 RAPID GRAM POSITIVE FLUOROGENIC 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 | S032 |
Date Received | 11/05/2001 |
Decision Date | 11/30/2001 |
Reclassified Date
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05/06/2003 |
Product Code |
LON |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES TO THE RAPID GRAM POSITIVE PROCEDURAL MANUALS FOR INTERPRETIVE CRITERIA FOR PENICILLIN AND AMPICILLIN WHEN TESTING STREPTOCOCCUS SPECIES OTHER THAN STREPTOCOCCUS PNEUMONIA. |
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