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

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 Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
510(k) Number K881064
Device Name HYGEIA GC TEST
Applicant
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Applicant Contact CANNON, PHD
Correspondent
Hygeia Sciences
330 Nevada St.
Newton,  MA  02160
Correspondent Contact CANNON, PHD
Regulation Number866.3390
Classification Product Code
LIR  
Date Received03/14/1988
Decision Date 06/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-