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, parathyroid hormone
510(k) Number K844735
Device Name PTH-RIA
Applicant
SYNCOR INTL. CORP.
12847 ARROYO ST.
SYLMAR,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
SYNCOR INTL. CORP.
12847 ARROYO ST.
SYLMAR,  CA  91342
Correspondent Contact ELEANOR V CHIU
Regulation Number862.1545
Classification Product Code
CEW  
Date Received12/04/1984
Decision Date 04/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-