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 Igg, Antigen, Antiserum, Control
510(k) Number K850583
Device Name SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G
Applicant
Applications Lab
10 Nonesuch Rd.
Scarborough,  ME  04074
Applicant Contact GLENN R IRISH
Correspondent
Applications Lab
10 Nonesuch Rd.
Scarborough,  ME  04074
Correspondent Contact GLENN R IRISH
Regulation Number866.5510
Classification Product Code
DEW  
Date Received02/13/1985
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-