510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851271Substantially Equivalent

Legionella Culture Confirmatin Kit

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

K851271 is the FDA 510(k) clearance record for LEGIONELLA CULTURE CONFIRMATIN KIT, a class II device, cleared for Gen-Probe, Inc. on under FDA product code GRO (Antisera, Fluorescent, All Types, Hemophilus Spp.). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K851271.

Clearance record

Decision date
Received
(98 days to decision)
Product code
GRO Antisera, Fluorescent, All Types, Hemophilus Spp.
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 9620 Chesapeake Dr., San Diego CA
Third party review
No

Clearances, product code GRO

Trailing 12 months

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

FDA records show no clearances under product code GRO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GRO, 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