510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K883907Substantially Equivalent

Sceptorpette System

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

K883907 is the FDA 510(k) clearance record for SCEPTORPETTE SYSTEM, a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K883907.

Clearance record

Decision date
Received
(42 days to decision)
Product code
LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1 Becton Dr., Franklin Lakes NJ
Third party review
No

Clearances, product code LRG

Trailing 12 months

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

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