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 K954437
Device Name THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
Applicant
Haemoscope Corp.
7855 Gross Point Rd.
Suite G4
Skokie,  IL  60077
Applicant Contact CHARMAINE SUTTON
Correspondent
Haemoscope Corp.
7855 Gross Point Rd.
Suite G4
Skokie,  IL  60077
Correspondent Contact CHARMAINE SUTTON
Regulation Number864.5400
Classification Product Code
GKP  
Date Received09/22/1995
Decision Date 01/30/1996
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
-
-