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 Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K931862
Device Name NINHYDRIN REAGENT
Applicant
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Applicant Contact MELISSA M TRAYLOR
Correspondent
Hardy Diagnostics
1430 W. Mccoy Ln.
Santa Maria,  CA  93455
Correspondent Contact MELISSA M TRAYLOR
Regulation Number866.2660
Classification Product Code
JTO  
Date Received04/14/1993
Decision Date 06/15/1993
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
-
-