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 Test, Heparin Neutralization
510(k) Number K874373
Device Name PT PRO-CLOT
Applicant
Probe-Tek, Inc.
3010 S. Washington Ave.
Lansing,  MI  48910
Applicant Contact FRANK LYMAN
Correspondent
Probe-Tek, Inc.
3010 S. Washington Ave.
Lansing,  MI  48910
Correspondent Contact FRANK LYMAN
Regulation Number864.7525
Classification Product Code
JBR  
Date Received10/26/1987
Decision Date 01/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-