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 Device, Specimen Collection
510(k) Number K860655
Device Name KULTSURE (CATALOGUE NO. M200)
Applicant
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Applicant Contact ALLEN CHAN
Correspondent
Ncs Diagnostics, Inc.
130 Matheson Blvd. E.
Mississauga, L4z 1y6,  CA
Correspondent Contact ALLEN CHAN
Regulation Number866.2900
Classification Product Code
LIO  
Date Received02/21/1986
Decision Date 03/06/1986
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
-
-