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 Calibrator, Secondary
510(k) Number K904698
Device Name SECONDARY CALIBRATORS
Applicant
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Applicant Contact BRUCE R WILLIAMS
Correspondent
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Correspondent Contact BRUCE R WILLIAMS
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/16/1990
Decision Date 11/28/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-