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 Control, Hemoglobin, Abnormal
510(k) Number K820787
Device Name HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL
Applicant
Helena Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Helena Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7415
Classification Product Code
JCM  
Date Received03/23/1982
Decision Date 04/08/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-