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510(k) K180681

Aptima Combo 2 Assay (Panther System) by Hologic, Inc. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2018
Date Received
March 15, 2018
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)
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  • K121710 — XPERT CT/NG (December 27, 2012)