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 Acid, Uric, Uricase (Colorimetric)
510(k) Number K970919
Device Name SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact SHERI HALL
Regulation Number862.1775
Classification Product Code
KNK  
Date Received03/12/1997
Decision Date 05/21/1997
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
-
-