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510(k) K231329

Aptima Neisseria gonorrhoeae Assay by Hologic, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2024
Date Received
May 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Neisseria
Device Class
Class II
Regulation Number
866.3390
Review Panel
MI
Submission Type

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  • K140448 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (May 20, 2014)
  • K140354 — ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (May 9, 2014)
  • K140887 — COBAS CT/NG V2.0 TEST (May 5, 2014)
  • K132270 — COBAS CT/NG V2.0 TEST (December 2, 2013)
  • K132251 — APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (October 17, 2013)
  • K121710 — XPERT CT/NG (December 27, 2012)