Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceMICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantDADE INTL., INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,, CA 95691
PMA NumberP870049
Supplement NumberS032
Date Received11/05/2001
Decision Date11/30/2001
Reclassified Date 05/06/2003
Product Code LON 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
-
-