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 Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K904031
Device Name CHEMA CHOL CHOLESTEROL SYSTEM
Applicant
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Applicant Contact ALBERT BLANCO
Correspondent
Texas Intl. Laboratories, Inc.
5601 Bintliff
Suite 500
Houston,  TX  77036
Correspondent Contact ALBERT BLANCO
Regulation Number862.1175
Classification Product Code
CHH  
Date Received08/31/1990
Decision Date 03/11/1991
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
-
-