510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864027Substantially Equivalent

Bbl Campyslide(tm) Test

BD Becton Dickinson Vacutainer Systems Preanalytic, Franklin Lakes NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864027 is the FDA 510(k) clearance record for BBL CAMPYSLIDE(TM) TEST, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code LQP (Campylobacter Spp.). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K864027.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LQP Campylobacter Spp.
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code LQP

Trailing 12 months

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

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