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 K140827
Device Name SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
Applicant
Sd Biosensor, Inc.
C-4th & 5th Floor Digital Empire Bldg. 980-3
Yeongtong-Dong, Yeongtong-Gu
Suwon-Si,  KR 443-702
Applicant Contact Yeon Park
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JJE   JJX  
Date Received04/01/2014
Decision Date 09/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-