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 C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K972160
Device Name CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
Applicant
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Applicant Contact BRUCE A CLINTON
Correspondent
Trinity Laboratories, Inc.
7517 Precision Dr., #107
Raleigh,  NC  27613
Correspondent Contact BRUCE A CLINTON
Regulation Number866.5270
Classification Product Code
DCK  
Date Received06/09/1997
Decision Date 08/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-