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 Lowry (Colorimetric), Total Protein
510(k) Number K821534
Device Name HEMATOLOGY DATA MANAGEMENT SYS
Applicant
Biovation, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biovation, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1635
Classification Product Code
JGP  
Date Received05/24/1982
Decision Date 06/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-