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 biuret (colorimetric), total protein
510(k) Number K880312
Device Name WAKO(TM) AUTOKIT TOTAL PROTEIN
Applicant
WAKO CHEMICALS, USA, INC.
12300 FORD RD.
SUITE 130
DALLAS,  TX  75234
Applicant Contact TOSHIHIKO ODA
Correspondent
WAKO CHEMICALS, USA, INC.
12300 FORD RD.
SUITE 130
DALLAS,  TX  75234
Correspondent Contact TOSHIHIKO ODA
Regulation Number862.1635
Classification Product Code
CEK  
Date Received01/25/1988
Decision Date 03/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-