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 System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K925425
Device Name SPECIFIC IGE EIA-TURBO ASSAY
Applicant
Hycor Biomedical, Inc.
217 Read St.
Portland,  ME  04103
Applicant Contact Anne Jepson
Correspondent
Hycor Biomedical, Inc.
217 Read St.
Portland,  ME  04103
Correspondent Contact Anne Jepson
Regulation Number866.5750
Classification Product Code
DHB  
Date Received10/27/1992
Decision Date 01/14/1993
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
-
-