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 Counter (Beta, Gamma) For Clinical Use
510(k) Number K946387
Device Name CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
Applicant
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact MARY A DELL
Correspondent
Capintec, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact MARY A DELL
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received11/25/1994
Decision Date 03/30/1995
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
-
-