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 Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
510(k) Number K943466
Device Name MINI S.F.T. (URINE PRESERVATIVE)
Applicant
Cambridge Diagnostic Products, Inc.
6880 NW 17th Ave.
Ft. Lauderdale,  FL  33309
Applicant Contact JACK H GOLD
Correspondent
Cambridge Diagnostic Products, Inc.
6880 NW 17th Ave.
Ft. Lauderdale,  FL  33309
Correspondent Contact JACK H GOLD
Regulation Number862.2050
Classification Product Code
LXG  
Date Received06/15/1994
Decision Date 05/24/1995
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
-
-