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 Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K981493
Device Name MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE RD.
INDIANAPOLIS,  IN  46268
Applicant Contact MARGO ENRIGHT
Correspondent
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 ZIONSVILLE RD.
INDIANAPOLIS,  IN  46268
Correspondent Contact MARGO ENRIGHT
Regulation Number862.1175
Classification Product Code
CHH  
Date Received04/27/1998
Decision Date 07/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-