510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090824Substantially Equivalent

Bd Probetec Chlamydia Trachomatis (CT) Qx Amplified DNA Assay

Becton Dickinson & Co, Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090824 is the FDA 510(k) clearance record for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY, a class I device, cleared for Becton, Dickinson & CO on under FDA product code MKZ (Dna Probe, Nucleic Acid Amplification, Chlamydia). FDA records list 345 510(k) clearances for Becton, Dickinson & CO, from to . As of , FDA records show no recalls naming K090824.

Clearance record

Decision date
Received
(68 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
Becton, Dickinson & CO 7loveton Cir., Sparks MD
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 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