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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K861901
Device Name MULTI-4 CO-OXIMETER CONTROL
Applicant
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact GEORGE LYNA
Correspondent
Allied Instrumentation Laboratory
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact GEORGE LYNA
Regulation Number862.1660
Classification Product Code
JJY  
Date Received05/16/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-