510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213280Substantially Equivalent

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

BD Kiestra B.V., Drachten, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213280 is the FDA 510(k) clearance record for BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App, a class II device, cleared for Bd Kiestra B.V. on under FDA product code QQY (Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms). FDA's definition for product code QQY reads: "Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media". FDA records list one 510(k) clearance for Bd Kiestra B.V. As of , FDA records show no recalls naming K213280.

Clearance record

Decision date
Received
(580 days to decision)
Product code
QQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Regulation
21 CFR 866.2190
Device class
Class II
Review panel
Microbiology
Applicant
Bd Kiestra B.V. Marconilaan 6, Drachten, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQY

Trailing 12 months

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

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