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 K080618
Device Name DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
Applicant
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Applicant Contact SAMUEL BURGOS
Correspondent
Jas Diagnostics, Inc.
7220 NW 58th St.
Miami,  FL  33166
Correspondent Contact SAMUEL BURGOS
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
CGA  
Date Received03/05/2008
Decision Date 05/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-