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 Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K954968
Device Name HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
Applicant
Tcpi, Inc.
15 Oak St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Tcpi, Inc.
15 Oak St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number862.1340
Classification Product Code
JIL  
Date Received10/27/1995
Decision Date 07/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-