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 Ige, Antigen, Antiserum, Control
510(k) Number K940183
Device Name HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
Applicant
Hycor Biomedical, Inc.
7572 Chapman Ave.
Garden Grove,  CA  92641
Applicant Contact THOMAS J FOLEY
Correspondent
Hycor Biomedical, Inc.
7572 Chapman Ave.
Garden Grove,  CA  92641
Correspondent Contact THOMAS J FOLEY
Regulation Number866.5510
Classification Product Code
DGC  
Date Received01/12/1994
Decision Date 05/17/1994
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
-
-