Medical Device Manufacturer · US , San Diego , CA

Gen-Probe, Inc. - FDA 510(k) Cleared Devices

62 submissions · 62 cleared · Since 1985

Recent clearances: APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER, APTIMA COMBO 2 ASSAY, GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

View 62 510(k) Devices ↓ Official Website

62

Total

62

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gen-Probe, Inc. Chemistry ✕

4 devices

1-4 of 4

Cleared Jan 23, 1991

GEN-PROBE LUMINOMETER-LEADER 450

Chemistry · 27d

Cleared Oct 04, 1990

GEN-PROBE PAL LUMINOMETER

Chemistry · 41d

Cleared Sep 27, 1990

GEN-PROBE LUMINOMETER-LEADER 50

Chemistry · 31d

Cleared Aug 21, 1987

GEN-PROBE (R) LUMINOMETER - LEADER (TM)

Chemistry · 70d