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 Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K972586
Device Name AIA-PACK TSH 3RD-GEN ASSAY
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 Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received07/11/1997
Decision Date 08/29/1997
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
Recalls CDRH Recalls
-
-