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 Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
510(k) Number K260041
Device Name MDx-Chex for BCP
Applicant
Streck, LLC
7002 S 109th St.
La Vista,  NE  68128
Applicant Contact Iris Servellon
Correspondent
Streck, LLC
7002 S 109th St.
La Vista,  NE  68128
Correspondent Contact Iris Servellon
Regulation Number866.3920
Classification Product Code
PMN  
Date Received01/06/2026
Decision Date 03/27/2026
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
-
-