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

CLIA - Clinical Laboratory Improvement Amendments
  • 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
Test System NameBECKMAN SYNCHRON CX 9 ALX SYSTEM  
Document NumberK950958
Parent Document NumberK950958
Analyte NameAlpha-hydroxybutyrate dehydrogenase (HBDH)
Analyte SpecialtyGeneral Chemistry
ComplexityMODERATE
Effective Date09/12/1997
Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K950958
Device Name SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact SHEI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact SHEI HALL
Regulation Number862.2160
Classification Product Code
JJE  
Date Received02/15/1995
Decision Date 05/08/1995
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
Recalls CDRH Recalls
-
-