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 automated colony counter
510(k) Number K893519
Device Name TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
Applicant
STATLABS, INC.
169 LONDON LN.
FRANKLIN,  TN  37064
Applicant Contact ANDY WOODS
Correspondent
STATLABS, INC.
169 LONDON LN.
FRANKLIN,  TN  37064
Correspondent Contact ANDY WOODS
Regulation Number866.2170
Classification Product Code
KZB  
Date Received05/08/1989
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-