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 Radioimmunoassay, Human Growth Hormone
510(k) Number K946247
Device Name IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3
Applicant
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Applicant Contact DAVE D SMITH
Correspondent
Nichols Institute
33608 Ortega Hwy.
San Juan Capistrano,  CA  92690
Correspondent Contact DAVE D SMITH
Regulation Number862.1370
Classification Product Code
CFL  
Date Received12/22/1994
Decision Date 06/23/1995
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
-
-