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 Assay, Glycosylated Hemoglobin
510(k) Number K871679
Device Name FOCUS-GHB
Applicant
Awareness Technology, Inc.
3481 SW Palm City Sch. Rd.
P.O. Box 1679
Palm City,  FL  34990
Applicant Contact MARY FREEMAN
Correspondent
Awareness Technology, Inc.
3481 SW Palm City Sch. Rd.
P.O. Box 1679
Palm City,  FL  34990
Correspondent Contact MARY FREEMAN
Regulation Number864.7470
Classification Product Code
LCP  
Date Received04/29/1987
Decision Date 07/28/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-