• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • 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
Device Classification Name dna-probe, strep pneumoniae
510(k) Number K902908
Device Name ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.
Applicant
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
san diego,  CA  92121
Applicant Contact connie kirby
Correspondent
GEN-PROBE, INC.
9880 CAMPUS POINT DR.
san diego,  CA  92121
Correspondent Contact connie kirby
Regulation Number866.3740
Classification Product Code
MCT  
Date Received07/02/1990
Decision Date 08/06/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-