510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000884Substantially Equivalent

Bd Probetec Et Mycobacterium Tuberculosis Complex (Ctb) Culture Identification Assay

Becton Dickinson Biosciences, Sparks MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000884 is the FDA 510(k) clearance record for BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY, a class I device, cleared for Becton Dickinson Biosciences on under FDA product code NDZ (Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis). FDA records list one 510(k) clearance for Becton Dickinson Biosciences. As of , FDA records show no recalls naming K000884.

Clearance record

Decision date
Received
(305 days to decision)
Product code
NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Regulation
21 CFR 866.3370
Device class
Class I
Review panel
Microbiology
Applicant
Becton Dickinson Biosciences 7loveton Cir., Sparks MD
510(k) summary
Summary
Third party review
No

Clearances, product code NDZ

Trailing 12 months

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

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