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

CLIA - Clinical Laboratory Improvement Amendments
  • 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
Test System NameTOSOH AIA NEXIA  
Document NumberK971103
Parent Document NumberK971103
Analyte NameT uptake (TU)
Analyte SpecialtyEndocrinology
ComplexityMODERATE
Effective Date09/26/1997
Device Classification Name Fluorometer, For Clinical Use
510(k) Number K971103
Device Name AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Applicant
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Applicant Contact LORI ROBINSON
Correspondent
Tosoh Medics, Inc.
373 Vintage Park Dr.
Suite D
Foster City,  CA  94404
Correspondent Contact LORI ROBINSON
Regulation Number862.2560
Classification Product Code
KHO  
Date Received03/26/1997
Decision Date 06/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-