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, Follicle-Stimulating Hormone
510(k) Number K043599
Device Name MOMENTS MENOPAUSE CHECK, MODEL 9113
Applicant
Phamatech, Inc.
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Applicant Contact CARL A MONGIOVI
Correspondent
Phamatech, Inc.
10151 Barnes Canyon Rd.
San Diego,  CA  92121
Correspondent Contact CARL A MONGIOVI
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received12/29/2004
Decision Date 02/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-