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 Apolipoproteins
510(k) Number K925702
Device Name NICHOLS APO B CHEMILUMINESCENCE ASSAY
Applicant
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact RAMAKRISHNAN
Correspondent
Nichols Institute Diagnostics
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact RAMAKRISHNAN
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received11/12/1992
Decision Date 12/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-