510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061413Substantially Equivalent

Aptima CT Assay on the Tigris Dts System

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

K061413 is the FDA 510(k) clearance record for APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM, a class I device, cleared for Gen-Probe, Inc. on under FDA product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K061413.

Clearance record

Decision date
Received
(144 days to decision)
Product code
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Gen-Probe, Inc. 10210 Genetic Center Dr., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code MKZ

Trailing 12 months

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

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