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, Control, White-Cell And Red-Cell Indices
510(k) Number K992887
Device Name STAK-CHEX PLUS RETICS
Applicant
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Applicant Contact PAUL KITTELSON
Correspondent
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Correspondent Contact PAUL KITTELSON
Regulation Number864.8625
Classification Product Code
GLQ  
Date Received08/27/1999
Decision Date 11/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-