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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K943729
Device Name DYE CHECK STRIPS 545-630
Applicant
Awareness Technology, Inc.
1995 SW Martin Hwy.
P.O. Box 1679
Palm City,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
Awareness Technology, Inc.
1995 SW Martin Hwy.
P.O. Box 1679
Palm City,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/02/1994
Decision Date 12/29/1994
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
-
-