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 Visual, Pregnancy Hcg, Prescription Use
510(k) Number K853925
Device Name QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
Applicant
NMS PHARMACEUTICALS, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Applicant Contact PERRY G RUCKER
Correspondent
NMS PHARMACEUTICALS, INC.
1533 MONROVIA AVE.
NEWPORT BEACH,  CA  92663
Correspondent Contact PERRY G RUCKER
Regulation Number862.1155
Classification Product Code
JHI  
Date Received09/24/1985
Decision Date 12/02/1985
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
-
-