510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132251Substantially Equivalent

Aptima Combo 2 Assay (Panther System)

Hologic / Gen-Probe Incorporated, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132251 is the FDA 510(k) clearance record for APTIMA COMBO 2 ASSAY (PANTHER SYSTEM), a class II device, cleared for Hologic / Gen-Probe Incorporated on under FDA product code LSL (Dna-Reagents, Neisseria). FDA records list one 510(k) clearance for Hologic / Gen-Probe Incorporated. As of , FDA records show 2 recalls naming K132251.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LSL Dna-Reagents, Neisseria
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Hologic / Gen-Probe Incorporated 10210 Genetic Center Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LSL

Trailing 12 months

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

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