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 Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K874408
Device Name MULTI-FUNCTION BLOOD GAS CONTROL
Applicant
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Applicant Contact R WILLIAMS
Correspondent
Bionostics, Inc.
Two Craig Rd.
Acton,  MA  01720
Correspondent Contact R WILLIAMS
Regulation Number862.1660
Classification Product Code
JJS  
Date Received10/28/1987
Decision Date 12/14/1987
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
-
-