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, Microtiter Diluting/Dispensing
510(k) Number K860617
Device Name POLYPET
Applicant
Instrumed, Inc.
P.O. Box N
Union Bridge,  MD  21791
Applicant Contact MEDICUS, PHD
Correspondent
Instrumed, Inc.
P.O. Box N
Union Bridge,  MD  21791
Correspondent Contact MEDICUS, PHD
Regulation Number866.2500
Classification Product Code
JTC  
Date Received02/19/1986
Decision Date 03/03/1986
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
-
-