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, Estriol
510(k) Number K903359
Device Name MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
Applicant
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Applicant Contact FRANCIS E CAPITANIO
Correspondent
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Correspondent Contact FRANCIS E CAPITANIO
Regulation Number862.1265
Classification Product Code
CGI  
Date Received07/25/1990
Decision Date 08/22/1990
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
-
-