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 Electrolyte Controls (Assayed And Unassayed)
510(k) Number K881655
Device Name SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
Applicant
Biomedical Research & Development Laboratories, Inc.
4301 Will Rogers Pkwy.
Suite 1000
Oklahoma City,  OK  73108
Applicant Contact SESHACHALAM DUTTA
Correspondent
Biomedical Research & Development Laboratories, Inc.
4301 Will Rogers Pkwy.
Suite 1000
Oklahoma City,  OK  73108
Correspondent Contact SESHACHALAM DUTTA
Regulation Number862.1660
Classification Product Code
JJR  
Date Received04/15/1988
Decision Date 05/27/1988
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
-
-