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 K875222
Device Name TOTAL PROTEIN
Applicant
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Applicant Contact LUIS LEON
Correspondent
CATACHEM, INC.
6 NORTH PEARL ST.
PORT CHESTER,  NY  10573
Correspondent Contact LUIS LEON
Regulation Number862.1635
Classification Product Code
CEK  
Date Received12/22/1987
Decision Date 01/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-