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 Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
510(k) Number K912680
Device Name ANTIGENZ CHLAMYDIA
Applicant
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact NANCY MALLINAK
Correspondent
Baxter Diagnostics, Inc.
Bartels Diagnostics Division
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact NANCY MALLINAK
Regulation Number866.3120
Classification Product Code
LJC  
Date Received06/03/1991
Decision Date 07/22/1991
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
-
-