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 Immunoassay Method, Troponin Subunit
510(k) Number K051925
Device Name CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
Applicant
Access Bio Incorporate
2033 Rt. 130 Unit H
Monmouth Jct.,  NJ  08852
Applicant Contact YOUNG HO CHOI
Correspondent
Access Bio Incorporate
2033 Rt. 130 Unit H
Monmouth Jct.,  NJ  08852
Correspondent Contact YOUNG HO CHOI
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Codes
DDR   JHT  
Date Received07/18/2005
Decision Date 11/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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
-
-