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 Mixture, Hematology Quality Control
510(k) Number K940181
Device Name SE-CHECK
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Applicant Contact HAL SORNSON
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
P.O. Box 37625
Omaha,  NE  68144
Correspondent Contact HAL SORNSON
Regulation Number864.8625
Classification Product Code
JPK  
Date Received01/12/1994
Decision Date 03/09/1994
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
-
-