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 K922138
Device Name VISTA ULTRASENSITIVE HTSH ASSAY
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Applicant Contact JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135
Correspondent Contact JR.
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/16/1992
Decision Date 07/21/1992
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
-
-