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 Culture Media, Single Biochemical Test
510(k) Number K842871
Device Name HIPPURATE TEST REAGENT
Applicant
Irvine Diagnostic Services
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Irvine Diagnostic Services
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2320
Classification Product Code
JSF  
Date Received07/23/1984
Decision Date 08/07/1984
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
-
-