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 Instrument, Coagulation, Automated
510(k) Number K001645
Device Name SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
Applicant
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Applicant Contact RADAMES RIESGO
Correspondent
Dade Behring, Inc.
7739 NW 48 St.
Suite 120
Miami,  FL  33166
Correspondent Contact RADAMES RIESGO
Regulation Number864.5400
Classification Product Code
GKP  
Date Received05/30/2000
Decision Date 08/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-