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 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
510(k) Number K790662
Device Name CENTRIFICHEM INORGANIC PHOSPHORUS
Applicant
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1520
Classification Product Code
CED  
Date Received04/06/1979
Decision Date 05/15/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-