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 Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K984070
Device Name ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
Applicant
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Applicant Contact ELIZABETH PLATT
Correspondent
BIO-RAD
9500 JERONIMO RD.
IRVINE,  CA  92618 -2017
Correspondent Contact ELIZABETH PLATT
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/16/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-