510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K053446Substantially Equivalent

Gen-Probe Aptima Assay for Chlamydia Trachomatis, Model 1088

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

K053446 is the FDA 510(k) clearance record for GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088, 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 K053446.

Clearance record

Decision date
Received
(225 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
Summary PDF
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MKZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260