• 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-reagents, neisseria
510(k) Number K872628
Device Name GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
raritan,  NJ  08869 -0606
Applicant Contact patricia bonness
Correspondent
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
raritan,  NJ  08869 -0606
Correspondent Contact patricia bonness
Regulation Number866.3390
Classification Product Code
LSL  
Date Received07/06/1987
Decision Date 12/21/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-