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 K921747
Device Name MICRO TRAK XL SYSTEM
Applicant
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Applicant Contact ROGERS, JR.
Correspondent
Syva Co.
3403 Yerba Buena Rd.
San Jose,  CA  95135 -1500
Correspondent Contact ROGERS, JR.
Regulation Number866.3120
Classification Product Code
LJC  
Date Received04/13/1992
Decision Date 10/01/1992
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
-
-