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 Radioassay, Intrinsic Factor Blocking Antibody
510(k) Number K071346
Device Name IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
Applicant
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228 -2120
Applicant Contact KEVIN LAWSON
Correspondent
Immco Diagnostics, Inc.
60 Pineview Dr.
Buffalo,  NY  14228 -2120
Correspondent Contact KEVIN LAWSON
Regulation Number862.1810
Classification Product Code
LIG  
Date Received05/14/2007
Decision Date 09/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-