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 Antigens, All Groups, Streptococcus Spp.
510(k) Number K862475
Device Name RESPIRASTICK ENZYME IMMUNOASSAY TEST
Applicant
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Applicant Contact DE MARCO
Correspondent
Orion Diagnostica, Inc.
71 Veronica Ave.
P.O. Box 218
Somerset,  NJ  08873
Correspondent Contact DE MARCO
Regulation Number866.3740
Classification Product Code
GTY  
Date Received06/30/1986
Decision Date 09/16/1986
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
-
-