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 Antisera, All Groups, Streptococcus Spp.
510(k) Number K864170
Device Name LEECO VIS-CUBE STREP A (EIA)
Applicant
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Applicant Contact LEE, PH.D.
Correspondent
Leeco Diagnostics, Inc.
21705 Evergreen
P.O. Box 5126
Southfield,  MI  48075
Correspondent Contact LEE, PH.D.
Regulation Number866.3740
Classification Product Code
GTZ  
Date Received10/24/1986
Decision Date 02/03/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-