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 Helicobacter Pylori
510(k) Number K980798
Device Name BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
Applicant
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Applicant Contact JEMO KANG, PH.D.
Correspondent
Princeton BioMeditech Corp.
4242 U.S. Rt. 1
Monmouth Junction,  NJ  08852
Correspondent Contact JEMO KANG, PH.D.
Regulation Number866.3110
Classification Product Code
LYR  
Date Received03/02/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-