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 Assay, Bart'S, Hemoglobin
510(k) Number K810976
Device Name ALPHA-THAL SCREEN TM CONTROL
Applicant
ISOLAB, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ISOLAB, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7500
Classification Product Code
LGL  
Date Received04/10/1981
Decision Date 05/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-