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 K901527
Device Name BIURET (COLORMETRIC), TOTAL PROTEIN
Applicant
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Applicant Contact PATEL, PHD
Correspondent
AMERICAN RESEARCH PRODUCTS CO.
30175 SOLON INDUSTRIAL PKWY.
P.O. BOX 39098
SOLON,  OH  44139
Correspondent Contact PATEL, PHD
Regulation Number862.1635
Classification Product Code
CEK  
Date Received04/02/1990
Decision Date 07/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-