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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K972868
Device Name TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
Applicant
BIONOSTICS, INC.
2 CRAIG RD.
ACTON,  MA  01720
Applicant Contact BRUCE R WILLIAMS
Correspondent
BIONOSTICS, INC.
2 CRAIG RD.
ACTON,  MA  01720
Correspondent Contact BRUCE R WILLIAMS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/04/1997
Decision Date 08/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-