Home / 510(k) Clearances / K974901

510(k) K974901

HYBRID CAPTURE SYSTEM CMV DNA ASSAY by Digene Corp. — Product Code LJO

K974901 is an FDA 510(k) premarket notification submitted by Digene Corp. for the device "HYBRID CAPTURE SYSTEM CMV DNA ASSAY". The FDA issued a decision of Substantially Equivalent on September 29, 1998. The device falls under product code LJO (Antigen, Iha, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Digene Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1998
Date Received
December 31, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Iha, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
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)
  • K010893 — MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (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)
  • K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER (February 6, 1998)
  • K971586 — DIGENE CERVICAL BRUSH (September 19, 1997)

Other clearances for product code LJO

  • K203612 — Capture-CMV (March 22, 2021)
  • K183571 — Capture-CMV (February 4, 2019)
  • K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (August 7, 2000)
  • K974456 — CMVGEN (May 1, 1998)
  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY (July 10, 1996)
  • K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (July 27, 1992)
  • K910003 — CYTOMEGALOVIRUS ANTIBODY SCREEN (March 20, 1991)
  • K852494 — CMV-IHA (September 16, 1985)
  • K841520 — CMV LATEX AGGLUTINATION TEST KIT (September 7, 1984)

FDA data resources