510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811434Substantially Equivalent

Sceptor Id Gram Negative Mic/id Panels

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

K811434 is the FDA 510(k) clearance record for SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS, a class I device, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on under FDA product code JSS (Kit, Identification, Enterobacteriaceae). FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K811434.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JSS Kit, Identification, Enterobacteriaceae
Regulation
21 CFR 866.2660
Device class
Class I
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 JSS

Trailing 12 months

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

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