510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K801648Substantially Equivalent

Trimethroprim 5Mcg. Sensi Disc.

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

K801648 is the FDA 510(k) clearance record for TRIMETHROPRIM 5MCG. SENSI DISC., a class II device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JTN (Susceptibility Test Discs, Antimicrobial). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K801648.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JTN Susceptibility Test Discs, Antimicrobial
Regulation
21 CFR 866.1620
Device class
Class II
Review panel
Microbiology
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1875 Eye St. NW Suite 625, Washington DC
Third party review
No

Clearances, product code JTN

Trailing 12 months
6 clearances under product code JTN in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JTN, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20262
August 20261
September 20260
October 20260