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, Calcitonin
510(k) Number K872880
Device Name CALCITONIN RIA KIT
Applicant
Endocrine Associates, Inc.
P.O. Box 891043
Houston,  TX  77289
Applicant Contact DILIP PATEL
Correspondent
Endocrine Associates, Inc.
P.O. Box 891043
Houston,  TX  77289
Correspondent Contact DILIP PATEL
Regulation Number862.1140
Classification Product Code
JKR  
Date Received07/21/1987
Decision Date 08/13/1987
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
-
-