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, thyroxine-binding globulin
510(k) Number K910677
Device Name IMMULITE(TM) T-UPTAKE
Applicant
CIRRUS DIAGNOSTICS, INC.
P.O. BOX 15
CHESTER,  NJ  07930
Applicant Contact ROBERT FENNELL
Correspondent
CIRRUS DIAGNOSTICS, INC.
P.O. BOX 15
CHESTER,  NJ  07930
Correspondent Contact ROBERT FENNELL
Regulation Number862.1685
Classification Product Code
CEE  
Date Received02/15/1991
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-