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, hematocrit, automated
510(k) Number K981426
Device Name STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
Applicant
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Applicant Contact PAUL W MACDONALD
Correspondent
NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM,  MA  02454 -9141
Correspondent Contact PAUL W MACDONALD
Regulation Number864.5600
Classification Product Code
GKF  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   CHL  
GKR   JFP   JGS   JIX   JJS   KHP  
Date Received04/16/1998
Decision Date 05/12/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-