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 Discs, Strips And Reagents, Microorganism Differentiation
510(k) Number K940124
Device Name EY-20 REAGENT TUBES
Applicant
E-Y Laboratories, Inc.
P.O. Box 1787
107 N. Amphlett Blvd.
San Mateo,  CA  94401
Applicant Contact LINDA M WERTZ
Correspondent
E-Y Laboratories, Inc.
P.O. Box 1787
107 N. Amphlett Blvd.
San Mateo,  CA  94401
Correspondent Contact LINDA M WERTZ
Regulation Number866.2660
Classification Product Code
JTO  
Date Received01/10/1994
Decision Date 08/26/1994
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
-
-