Modification to Hybrid Capture II CT/Gc Test, Model 03M90-01

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K010891 ↗

FDA Product Code

LSK

Device Class

Class I

Regulation

21 CFR Part 866.3120

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Hybrid Capture System Cmv DNA Assay

  Class II

  FDA 510(k) K974901 Active Cleared 29 Sep 1998

• Hybrid Capture II Gc-Id

  Class II

  FDA 510(k) K981485 Active Cleared 29 Nov 1999

• Digene Dml 2000 Microplate Luminometer

  Class I

  FDA 510(k) K980120 Active Cleared 6 Feb 1998

• Modification to Hybrid Capture 2 Gc-Id DNA Test, Model 03M92-01

  Class II

  FDA 510(k) K010893 Active Cleared 24 Sep 2001

• Digene Cervical Brush

  Class II

  FDA 510(k) K971586 Active Cleared 19 Sep 1997

• Hybrid Capture II CT-Id Test

  Class I

  FDA 510(k) K990023 Active Cleared 25 Oct 1999

See all devices from Digene Corp. →