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 Bromcresol Green Dye-Binding, Albumin
510(k) Number K010877
Device Name CHEMWELL, MODEL 2900
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 Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDO   CDQ   CEK   CFR   CGX  
CHH   CIT   CJE   CJW   JQB  
Date Received03/23/2001
Decision Date 05/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-