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.
 
DeviceOMNISCEPT(TM) KB SYSTEM
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantANALYTICAL PRODUCTS, INC.
200 EXPRESS STREET
PLAINVIEW, NY 11803-
PMA NumberP800029
Supplement NumberS005
Date Received12/03/1982
Decision Date07/05/1983
Reclassified Date 05/06/2003
Product Code LON 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
-
-