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 Legionella, Spp., Elisa
510(k) Number K911356
Device Name LEGIONELLA STAT IGG/IGM TEST KIT
Applicant
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Applicant Contact LEIF E OLSEN
Correspondent
Whittaker Bioproducts, Inc.
8830 Brigg Ford Rd.
Walkersville,  MD  21793
Correspondent Contact LEIF E OLSEN
Regulation Number866.3300
Classification Product Code
MJH  
Date Received03/28/1991
Decision Date 07/30/1992
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
-
-