• 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 phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K843030
Device Name INORGANIC PHOSPHORUS ASSAY KIT
Applicant
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 newland crescent
charlottetown
canada, 
Correspondent
DIAGNOSTIC CHEMICALS, LTD. (USA)
4 newland crescent
charlottetown
canada, 
Regulation Number862.1580
Classification Product Code
CEO  
Date Received08/01/1984
Decision Date 08/27/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-