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 Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
510(k) Number K200866
Device Name Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Applicant Contact Anila Tarte
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Correspondent Contact Anila Tarte
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ  
Date Received04/01/2020
Decision Date 05/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-