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 phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K823691
Device Name PHOSPHORUS REAGENT SET
Applicant
OMEGA MEDICAL ELECTRONICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OMEGA MEDICAL ELECTRONICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1580
Classification Product Code
CEO  
Date Received12/08/1982
Decision Date 01/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-