510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860782Substantially Equivalent

Gen-Probe Mycobacterium Rapid Confirmation System

Hologic, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860782 is the FDA 510(k) clearance record for GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM, a class I device, cleared for Gen-Probe, Inc. on under FDA product code LQF (Dna-Reagents, Mycobacterium Spp.). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K860782.

Clearance record

Decision date
Received
(121 days to decision)
Product code
LQF Dna-Reagents, Mycobacterium Spp.
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 9620 Chesapeake Dr., San Diego CA
Third party review
No

Clearances, product code LQF

Trailing 12 months

FDA records hold no clearances under product code LQF in the trailing twelve months.

FDA records show no clearances under product code LQF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260