510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813442Substantially Equivalent

Cefinase Tm Discs

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

K813442 is the FDA 510(k) clearance record for CEFINASE TM DISCS, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JTO (Discs, Strips And Reagents, Microorganism Differentiation). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K813442.

Clearance record

Decision date
Received
(19 days to decision)
Product code
JTO Discs, Strips And Reagents, Microorganism Differentiation
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JTO

Trailing 12 months

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

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