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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K132751
Device Name MULTICHEM S PLUS / S PLUS (ASSAYED)
Applicant
Techno-Path Manufacturing , Ltd.
325 Big Elm St.
Highland Village,  TX  75077
Applicant Contact STEPHANIE G GARTH
Correspondent
Techno-Path Manufacturing , Ltd.
325 Big Elm St.
Highland Village,  TX  75077
Correspondent Contact STEPHANIE G GARTH
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/03/2013
Decision Date 10/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-