Home / 510(k) Clearances / K010893

510(k) K010893

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 by Digene Corp. — Product Code LSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2001
Date Received
March 26, 2001
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

Other clearances by Digene Corp.

  • K010891 — MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (September 25, 2001)
  • K010892 — MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (September 24, 2001)
  • K981567 — HYBRID CAPTURE II CT/GC TEST (February 29, 2000)
  • K981485 — HYBRID CAPTURE II GC-ID (November 29, 1999)
  • K990023 — HYBRID CAPTURE II CT-ID TEST (October 25, 1999)
  • K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY (September 29, 1998)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K971586 — DIGENE CERVICAL BRUSH (September 19, 1997)

Other clearances for product code LSL

  • K231329 — Aptima Neisseria gonorrhoeae Assay (January 26, 2024)
  • K180681 — Aptima Combo 2 Assay (Panther System) (June 13, 2018)
  • K173887 — cobas CT/NG for use on cobas 6800/8800 systems (March 21, 2018)
  • K173840 — Xpert CT/NG (March 16, 2018)
  • K163184 — cobas® CT/NG v2.0 Test (February 9, 2017)
  • 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)